Postprandial HypoglycemiaPhase 2AnPHy-ReDNCT07580079
Anakinra for the Treatment of Postprandial Hypoglycemia in a Patient With Total Gastrectomy and End-Stage Renal Disease
A Phase 2 study testing Anakinra (interleukin-1 receptor antagonist) in people with Postprandial Hypoglycemia and End-stage Renal Disease (ESRD), run by Marc Donath at 1 site in Switzerland.
Trial summary
Post-meal low blood sugar (postprandial hypoglycemia) is a common problem after certain stomach surgeries like gastric bypass or stomach removal. It usually happens 1 to 3 hours after eating and can cause symptoms such as tiredness, hunger, sweating, dizziness, trouble speaking, or even fainting. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Postprandial Hypoglycemia, End-stage Renal Disease (ESRD), Gastrectomy
- What is being tested?
- Anakinra (interleukin-1 receptor antagonist)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2026to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
This is an N-of-1 Trial, tailored-designed to a single participant.
- total gastrectomy
- severe episodes of postprandial hypoglycaemia after total gastrectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Kantonsspital Olten
Olten, Canton of Solothurn, 4600
Matthias Hepprich, PD Dr. med., +41 61 685 89 40, endokrinologie@claraspital.ch
Matthias Hepprich, PD Dr. med.
About this study
Official title: Anakinra for the Treatment of Recurrent Postprandial Hypoglycemia After Total Gastrectomy in a Patient With End-Stage Renal Disease
Post-meal low blood sugar (postprandial hypoglycemia) is a common problem after certain stomach surgeries like gastric bypass or stomach removal. It usually happens 1 to 3 hours after eating and can cause symptoms such as tiredness, hunger, sweating, dizziness, trouble speaking, or even fainting. Right now, there is no approved medication for this condition-only a careful diet reduced in sugars and refined carbohydrates can sometimes help reduce symptoms.
The AnPHy-ReD study is a personalized research study, designed for just one patient. This patient is a 52-year-old man who has been struggling with severe post-meal low blood sugar ever since his stomach was removed due to tumor in 2017. He also has end-stage kidney disease and needs dialysis three times a week.
Read more
The study is being conducted at the Cantonal Hospital of Olten in Switzerland and lasts 10 weeks, including 24 study visits. Most of these visits will happen during the patient's regular dialysis sessions. For 6 weeks, the patient will take either the drug Anakinra or a placebo (a substance with no active ingredient), in a randomly chosen order. Neither the patient nor the doctors will know which one he is taking at any given time.
During the study, the medical team will perform various tests, including physical check-ups and blood samples to look at sugar levels, various hormone levels and inflammation in the body. The patient will also wear a continuous glucose monitor (CGM) to track his blood sugar levels 24/7. In addition, he will do several mixed meal tests-this means drinking a shake containing fats, proteins, and sugars during a study appointment to see in real time how his body processes food, with doctors measuring changes in blood sugar, hormone and inflammation markers over time. During the study duration any side effects or symptoms will be closely monitored.
At the end of the study, the team will compare the results between the times the patient took Anakinra and the times he took the placebo. This will help find out if Anakinra can reduce sharp drops in blood sugar after meals and improve his overall condition.
- Conditions
- Postprandial Hypoglycemia, End-stage Renal Disease (ESRD), Gastrectomy, Glucose Metabolism Disorders, Inflammation, Gastric Bypass Surgery
- Being tested
- Anakinra (interleukin-1 receptor antagonist), Placebo Comparator (0.9% NaCl)
- Keywords
- Postprandial Hypoglycemia, End-Stage Renal Disease, Anakinra, Gastric Bypass, IL-1 receptor antagonist, Inflammation
- Medical subject headings
- Hypoglycemia, Kidney Failure, Chronic, Glucose Metabolism Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anakinra (interleukin-1 receptor antagonist)Drug
Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). It is a clear, colourless-to-white solution, provided as a 150mg/mL solution in pre-filled syringes, each containing of 100 mg of Anakinra in 0.67ml.
On the assigned study days, the patient will receive in a double-blind manner 100 mg of Anakinra intravenously through the hemodialysis circuit, administered 30 minutes before the end of the dialysis session.
Placebo Comparator (0.9% NaCl)Drug
Placebo comparator will be 0.9% saline solution. A similar size and type of syringe will be used as for the Anakinra syringe making it difficult to distinguish which treatment of the two the patient is receiving.
The patient will receive 0.9% saline solution intravenously through the haemodialysis circuit 30 minutes before the end of the dialysis session, following the same administration procedure as Anakinra to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Treatment Periods | Placebo comparator | The interventional period consists of four treatment blocks, each containing four visits. During each visit, the patient receives either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) is randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial.
Study visits take place during the patient's regular dialysis sessions. On each visit, the assigned treatment is administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel. Receives: Drug: Placebo Comparator (0.9% NaCl) |
| Anakinra Treatment Periods | Experimental | The interventional period consists of four treatment blocks, each containing four visits. During each visit, the patient receives either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) is randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial. Study visits take place during the patient's regular dialysis sessions. On each visit, the assigned treatment is administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel. Receives: Drug: Anakinra (interleukin-1 receptor antagonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Amplitude of Sensor Glucose Excursions (MAGE) during Anakinra treatment compared to placebo
Mean Amplitude of Sensor Glucose Excursions (MAGE) during Anakinra treatment compared to placebo, assessed using cumulative data from Continuous Glucose Monitoring System from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo).
Measured: Through the 40-day interventional period
Prevalence and severity of postprandial hypoglycaemia symptoms during Anakinra treatment compared to placebo
Prevalence and severity of postprandial hypoglycaemia symptoms during Anakinra treatment compared to placebo, assessed using cumulative data from Continuous Glucose Monitoring from all 48-hour treatment periods.
Post-prandial hypoglycaemia symptoms and their severity will be evaluated by the patient using the Edinburgh Hypoglycemia Symptom Scale (EHSS) and are accompanied by a decrease in blood glucose levels within the postprandial period as evaluated through the CGMS.
The postprandial period is defined as the 3 hours following meal intake. A minimum blood glucose cut-off value is not required for symptom reporting. Each treatment period spans the 48 hours following study-drug administration (Anakinra or Placebo).
Measured: Through the 40-day interventional period
Secondary outcomes (10)
Time Below Range (TBR)
Time Below Range (TBR): The percentage and total duration of sensor glucose readings below thresholds of 3.3 mmol/L, 3.0 mmol/L, and 2.7 mmol/L during Anakinra treatment compared to placebo, assessed using cumulative data from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo).
Measured: Through the 40-day interventional period
Time in hyperglycaemia
Time in hyperglycaemia: The percentage and total duration of sensor glucose readings above 10 mmol/L during Anakinra treatment compared to Placebo, assessed using cumulative data from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo).
Measured: Through the 40-day interventional period
Pattern of Sensor Glucose
Pattern of Sensor Glucose: The slope of postprandial glucose measurements calculated as the maximal rate of increase and decrease of glucose levels observed over 20 minutes in the postprandial period, compared between Anakinra treatment and placebo, based on data from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo). The postprandial period is defined as the 3 hours following meal intake.
Measured: Through the 40-day interventional period
Comparison of Glycemic Variability and Extremes Between Interventional and Screening Period
Comparison of the entire interventional period with the screening period regarding to the following parameters as defined above: Time Below Range, Time in hyperglycaemia, Pattern of Sensor Glucose, and Mean Amplitude of Glucose Excursions.
Measured: From screening at Day -14 through the 40-day interventional period
Effect of Anakinra vs. Placebo on Glycemic and Hormonal Responses During Mixed Meal Tolerance Test
Changes following treatment with Anakinra compared to placebo during a Mixed Meal Tolerance Test in the AUC, peak and nadir values, and slopes of:
- Glucose
- Insulin
- c-peptide
- GLP-1
- Glucagon
- Cortisol
Measured: Immediately after Mixed-meal tolerance test
Changes in Fasting Metabolic and Inflammatory Biomarkers After the Interventional Period Compared to Baseline
Changes following the entire interventional period in levels of fasting insulin, c-peptide, glucagon, HbA1c, IL-1Ra, IL-6, TNF-a, IL-18 and hsCRP as compared to Baseline.
Measured: Through the 40-day interventional period
Comparison of Prevalence and Severity of Postprandial Hypoglycemia Symptoms Between the Interventional and Screening Periods
Prevalence and severity of postprandial hypoglycaemia symptoms during the whole interventional period compared to the Screening period.
Post-prandial hypoglycaemia symptoms and their severity will be evaluated by the patient using the Edinburgh Hypoglycemia Symptom Scale (EHSS) and are accompanied by a decrease in blood glucose levels within the postprandial period as evaluated through the CGMS.
The postprandial period is defined as the 3 hours following meal intake. A minimum blood glucose cut-off value is not required for symptom reporting.-Each treatment period spans the 48 hours following study-drug administration (Anakinra or Placebo).
Measured: From screening at Day -14 through the 40-day interventional period
Subjective patient's daily preference for treatment period
The patient will be asked to provide feedback on the treatment periods, indicating which study days he found the treatment more tolerable or beneficial. This subjective assessment will take into account factors such as comfort, side effects, and overall experience during the interventional period.
Measured: Through the 40-day interventional period
Adverse events of interest
Adverse events of interest: AEs of interest include adverse events that can be expected during a treatment with Anakinra.
- Identification of hypersensitivity reaction during the Interventional period.
- Detection of any infection during the interventional period.
- Detection of Neutropenia during the interventional period, defined as absolute neutrophil count <1000/mm³.
- Detection of Thrombocytopenia during the Interventional period, defined as platelet count <100 000/mm³.
Measured: From first dose of anakinra (Visit 4, Day 3) through the 40-day interventional Period and 15-day follow-up period
Serious Adverse Events
A Serious Adverse Event (SAE) is classified as any untoward medical occurrence that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: From screening on Day -14 through the 40-day interventional period and 15-day follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study startJul 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Postprandial HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The interventional period will consist of four treatment blocks, each containing four visits. During each visit, the patient will receive either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) will be randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial. The visits are taking place parallel to the patient's scheduled dialysis treatment. On each visit, the assigned treatment will be administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marc Donath
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baden
- Responsible party
- Sponsor-investigator, Marc Donath, Kantonsspital Baden
- Investigators
- Matthias Hepprich, PD Dr. med., Principal investigator, University of Basel, Claraspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580079
- Sponsor's protocol ID
- 2025-00684
- Other IDs
- 2025
- Acronym
- AnPHy-ReD
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vaurs C, Brun JF, Bertrand M, Burcelin R, du Rieu MC, Anduze Y, Hanaire H, Ritz P. Post-prandial hypoglycemia results from a non-glucose-dependent inappropriate insulin secretion in Roux-en-Y gastric bypassed patients. Metabolism. 2016 Mar;65(3):18-26. doi: 10.1016/j.metabol.2015.10.020. Epub 2015 Oct 23.
PubMed 26892512Nannipieri M, Belligoli A, Guarino D, Busetto L, Moriconi D, Fabris R, Mari A, Baldi S, Anselmino M, Foletto M, Vettor R, Ferrannini E. Risk Factors for Spontaneously Self-Reported Postprandial Hypoglycemia After Bariatric Surgery. J Clin Endocrinol Metab. 2016 Oct;101(10):3600-3607. doi: 10.1210/jc.2016-1143. Epub 2016 Jun 23.
PubMed 27336358Patti ME, Goldfine AB. Hypoglycemia after gastric bypass: the dark side of GLP-1. Gastroenterology. 2014 Mar;146(3):605-8. doi: 10.1053/j.gastro.2014.01.038. Epub 2014 Jan 24. No abstract available.
PubMed 24468184Ohrstrom CC, Worm D, Hansen DL. Postprandial hyperinsulinemic hypoglycemia after Roux-en-Y gastric bypass: an update. Surg Obes Relat Dis. 2017 Feb;13(2):345-351. doi: 10.1016/j.soard.2016.09.025. Epub 2016 Sep 28.
PubMed 27865808Salehi M, Gastaldelli A, D'Alessio DA. Blockade of glucagon-like peptide 1 receptor corrects postprandial hypoglycemia after gastric bypass. Gastroenterology. 2014 Mar;146(3):669-680.e2. doi: 10.1053/j.gastro.2013.11.044. Epub 2013 Dec 4.
PubMed 24315990Botros N, Rijnaarts I, Brandts H, Bleumink G, Janssen I, de Boer H. Effect of carbohydrate restriction in patients with hyperinsulinemic hypoglycemia after Roux-en-Y gastric bypass. Obes Surg. 2014 Nov;24(11):1850-5. doi: 10.1007/s11695-014-1319-6.
PubMed 24902654Roslin MS, Oren JH, Polan BN, Damani T, Brauner R, Shah PC. Abnormal glucose tolerance testing after gastric bypass. Surg Obes Relat Dis. 2013 Jan-Feb;9(1):26-31. doi: 10.1016/j.soard.2011.11.023. Epub 2012 Jan 27.
PubMed 22398113Kefurt R, Langer FB, Schindler K, Shakeri-Leidenmuhler S, Ludvik B, Prager G. Hypoglycemia after Roux-En-Y gastric bypass: detection rates of continuous glucose monitoring (CGM) versus mixed meal test. Surg Obes Relat Dis. 2015 May-Jun;11(3):564-9. doi: 10.1016/j.soard.2014.11.003. Epub 2014 Nov 13.
PubMed 25737101Yang BB, Baughman S, Sullivan JT. Pharmacokinetics of anakinra in subjects with different levels of renal function. Clin Pharmacol Ther. 2003 Jul;74(1):85-94. doi: 10.1016/S0009-9236(03)00094-8.
PubMed 12844139Dember LM, Hung A, Mehrotra R, Hsu JY, Raj DS, Charytan DM, Mc Causland FR, Regunathan-Shenk R, Landis JR, Kimmel PL, Kliger AS, Himmelfarb J, Ikizler TA; Hemodialysis Novel Therapies Consortium. A randomized controlled pilot trial of anakinra for hemodialysis inflammation. Kidney Int. 2022 Nov;102(5):1178-1187. doi: 10.1016/j.kint.2022.06.022. Epub 2022 Jul 19.
PubMed 35863559Zimmermann J, Herrlinger S, Pruy A, Metzger T, Wanner C. Inflammation enhances cardiovascular risk and mortality in hemodialysis patients. Kidney Int. 1999 Feb;55(2):648-58. doi: 10.1046/j.1523-1755.1999.00273.x.
PubMed 9987089Eustace JA, Astor B, Muntner PM, Ikizler TA, Coresh J. Prevalence of acidosis and inflammation and their association with low serum albumin in chronic kidney disease. Kidney Int. 2004 Mar;65(3):1031-40. doi: 10.1111/j.1523-1755.2004.00481.x.
PubMed 14871424Hepprich M, Wiedemann SJ, Schelker BL, Trinh B, Starkle A, Geigges M, Loliger J, Boni-Schnetzler M, Rudofsky G, Donath MY. Postprandial Hypoglycemia in Patients after Gastric Bypass Surgery Is Mediated by Glucose-Induced IL-1beta. Cell Metab. 2020 Apr 7;31(4):699-709.e5. doi: 10.1016/j.cmet.2020.02.013. Epub 2020 Mar 19.
PubMed 32197070Dror E, Dalmas E, Meier DT, Wueest S, Thevenet J, Thienel C, Timper K, Nordmann TM, Traub S, Schulze F, Item F, Vallois D, Pattou F, Kerr-Conte J, Lavallard V, Berney T, Thorens B, Konrad D, Boni-Schnetzler M, Donath MY. Postprandial macrophage-derived IL-1beta stimulates insulin, and both synergistically promote glucose disposal and inflammation. Nat Immunol. 2017 Mar;18(3):283-292. doi: 10.1038/ni.3659. Epub 2017 Jan 16.
PubMed 28092375Goldfine AB, Mun EC, Devine E, Bernier R, Baz-Hecht M, Jones DB, Schneider BE, Holst JJ, Patti ME. Patients with neuroglycopenia after gastric bypass surgery have exaggerated incretin and insulin secretory responses to a mixed meal. J Clin Endocrinol Metab. 2007 Dec;92(12):4678-85. doi: 10.1210/jc.2007-0918. Epub 2007 Sep 25.
PubMed 17895322
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anakinra for the Treatment of Recurrent Postprandial Hypoglycemia After Total Gastrectomy in a Patient With End-Stage Renal Disease
- ClinicalTrials.gov ID
- NCT07580079
- Acronym / sponsor ID
- AnPHy-ReD / 2025-00684
- Conditions
- Postprandial Hypoglycemia, End-stage Renal Disease (ESRD), Gastrectomy, Glucose Metabolism Disorders, Inflammation, Gastric Bypass Surgery
- Keywords
- Postprandial Hypoglycemia, End-Stage Renal Disease, Anakinra, Gastric Bypass, IL-1 receptor antagonist, Inflammation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Marc DonathUniversity, hospital or other
- Collaborators
- Kantonsspital Baden
- Study start
- Jul 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post-meal low blood sugar (postprandial hypoglycemia) is a common problem after certain stomach surgeries like gastric bypass or stomach removal. It usually happens 1 to 3 hours after eating and can cause symptoms such as tiredness, hunger, sweating, dizziness, trouble speaking, or even fainting. Right now, there is no approved medication for this condition-only a careful diet reduced in sugars and refined carbohydrates can sometimes help reduce symptoms.
The AnPHy-ReD study is a personalized research study, designed for just one patient. This patient is a 52-year-old man who has been struggling with severe post-meal low blood sugar ever since his stomach was removed due to tumor in 2017. He also has end-stage kidney disease and needs dialysis three times a week.
The study is being conducted at the Cantonal Hospital of Olten in Switzerland and lasts 10 weeks, including 24 study visits. Most of these visits will happen during the patient's regular dialysis sessions. For 6 weeks, the patient will take either the drug Anakinra or a placebo (a substance with no active ingredient), in a randomly chosen order. Neither the patient nor the doctors will know which one he is taking at any given time.
During the study, the medical team will perform various tests, including physical check-ups and blood samples to look at sugar levels, various hormone levels and inflammation in the body. The patient will also wear a continuous glucose monitor (CGM) to track his blood sugar levels 24/7. In addition, he will do several mixed meal tests-this means drinking a shake containing fats, proteins, and sugars during a study appointment to see in real time how his body processes food, with doctors measuring changes in blood sugar, hormone and inflammation markers over time. During the study duration any side effects or symptoms will be closely monitored.
At the end of the study, the team will compare the results between the times the patient took Anakinra and the times he took the placebo. This will help find out if Anakinra can reduce sharp drops in blood sugar after meals and improve his overall condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The interventional period will consist of four treatment blocks, each containing four visits. During each visit, the patient will receive either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) will be randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial. The visits are taking place parallel to the patient's scheduled dialysis treatment. On each visit, the assigned treatment will be administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel.
| Arm | Type | Receives |
|---|---|---|
| Placebo Treatment Periods | Placebo comparator | Drug: Placebo Comparator (0.9% NaCl)The interventional period consists of four treatment blocks, each containing four visits. During each visit, the patient receives either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) is randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial. Study visits take place during the patient's regular dialysis sessions. On each visit, the assigned treatment is administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel. |
| Anakinra Treatment Periods | Experimental | Drug: Anakinra (interleukin-1 receptor antagonist)The interventional period consists of four treatment blocks, each containing four visits. During each visit, the patient receives either Anakinra (A) or placebo (P) in a double-blinded manner, according to a randomized schedule. The sequence within each block (e.g., A-A-P-P or P-A-A-P) is randomly assigned in advance by an independent scientist, ensuring a balanced and unbiased comparison of treatments throughout the trial. Study visits take place during the patient's regular dialysis sessions. On each visit, the assigned treatment is administered via the hemodialysis blood circuit over 1 minute during the last 30 minutes of each dialysis session by the dialysis personnel. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anakinra (interleukin-1 receptor antagonist)Anakinra (Kineret®; r-metHuIL-1ra, Swedish Orphan Biovitrum AB) is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). It is a clear, colourless-to-white solution, provided as a 150mg/mL solution in pre-filled syringes, each containing of 100 mg of Anakinra in 0.67ml. On the assigned study days, the patient will receive in a double-blind manner 100 mg of Anakinra intravenously through the hemodialysis circuit, administered 30 minutes before the end of the dialysis session. | Drug | Anakinra Treatment Periods |
| Placebo Comparator (0.9% NaCl)Placebo comparator will be 0.9% saline solution. A similar size and type of syringe will be used as for the Anakinra syringe making it difficult to distinguish which treatment of the two the patient is receiving. The patient will receive 0.9% saline solution intravenously through the haemodialysis circuit 30 minutes before the end of the dialysis session, following the same administration procedure as Anakinra to maintain blinding. | Drug | Placebo Treatment Periods |
Primary outcome
Mean Amplitude of Sensor Glucose Excursions (MAGE) during Anakinra treatment compared to placebo
Time frame: Through the 40-day interventional period
Mean Amplitude of Sensor Glucose Excursions (MAGE) during Anakinra treatment compared to placebo, assessed using cumulative data from Continuous Glucose Monitoring System from all 48-hour treatment periods (48 hours following study-drug administration, Anakinra or Placebo).
Prevalence and severity of postprandial hypoglycaemia symptoms during Anakinra treatment compared to placebo
Time frame: Through the 40-day interventional period
Prevalence and severity of postprandial hypoglycaemia symptoms during Anakinra treatment compared to placebo, assessed using cumulative data from Continuous Glucose Monitoring from all 48-hour treatment periods. Post-prandial hypoglycaemia symptoms and their severity will be evaluated by the patient using the Edinburgh Hypoglycemia Symptom Scale (EHSS) and are accompanied by a decrease in blood glucose levels within the postprandial period as evaluated through the CGMS. The postprandial period is defined as the 3 hours following meal intake. A minimum blood glucose cut-off value is not required for symptom reporting. Each treatment period spans the 48 hours following study-drug administration (Anakinra or Placebo).
10 secondary outcomes
Time Below Range (TBR)
Time frame: Through the 40-day interventional period
Time in hyperglycaemia
Time frame: Through the 40-day interventional period
Pattern of Sensor Glucose
Time frame: Through the 40-day interventional period
Comparison of Glycemic Variability and Extremes Between Interventional and Screening Period
Time frame: From screening at Day -14 through the 40-day interventional period
Effect of Anakinra vs. Placebo on Glycemic and Hormonal Responses During Mixed Meal Tolerance Test
Time frame: Immediately after Mixed-meal tolerance test
Changes in Fasting Metabolic and Inflammatory Biomarkers After the Interventional Period Compared to Baseline
Time frame: Through the 40-day interventional period
Comparison of Prevalence and Severity of Postprandial Hypoglycemia Symptoms Between the Interventional and Screening Periods
Time frame: From screening at Day -14 through the 40-day interventional period
Subjective patient's daily preference for treatment period
Time frame: Through the 40-day interventional period
Adverse events of interest
Time frame: From first dose of anakinra (Visit 4, Day 3) through the 40-day interventional Period and 15-day follow-up period
Serious Adverse Events
Time frame: From screening on Day -14 through the 40-day interventional period and 15-day follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Background: PubMed 26892512Vaurs C, Brun JF, Bertrand M, Burcelin R, du Rieu MC, Anduze Y, Hanaire H, Ritz P. Post-prandial hypoglycemia results from a non-glucose-dependent inappropriate insulin secretion in Roux-en-Y gastric bypassed patients. Metabolism. 2016 Mar;65(3):18-26. doi: 10.1016/j.metabol.2015.10.020. Epub 2015 Oct 23.
- Background: PubMed 27336358Nannipieri M, Belligoli A, Guarino D, Busetto L, Moriconi D, Fabris R, Mari A, Baldi S, Anselmino M, Foletto M, Vettor R, Ferrannini E. Risk Factors for Spontaneously Self-Reported Postprandial Hypoglycemia After Bariatric Surgery. J Clin Endocrinol Metab. 2016 Oct;101(10):3600-3607. doi: 10.1210/jc.2016-1143. Epub 2016 Jun 23.
- Background: PubMed 24468184Patti ME, Goldfine AB. Hypoglycemia after gastric bypass: the dark side of GLP-1. Gastroenterology. 2014 Mar;146(3):605-8. doi: 10.1053/j.gastro.2014.01.038. Epub 2014 Jan 24. No abstract available.
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- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthias Hepprich, PD Dr. med. principal investigator
University of Basel, Claraspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anakinra (interleukin-1 receptor antagonist) in people with Postprandial Hypoglycemia and End-stage Renal Disease (ESRD), run by Marc Donath at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Donath, Prof. Dr. Med (+41 56 486 25 52, marc.donath@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Amplitude of Sensor Glucose Excursions (MAGE) during Anakinra treatment compared to placebo (time frame: Through the 40-day interventional period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07580079, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.