Chronic Kidney DiseasePhase 2/3GLUTREPRONCT05998837
GLUcose Transport and REnalPROtection in Chronic Kidney Disease
A Phase 2/3 study testing Dapagliflozin 10mg Tab in people with Chronic Kidney Disease and Diabetes Mellitus, Type 2, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
Trial summary
This is a single-center, double blind, randomized, parallel-arms study designed to investigate the effects of a six-month treatment with the SGLT2i dapagliflozin on markers of kidney senescence, inflammation and tubulointerstitial damage compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease, Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Dapagliflozin 10mg Tab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 13 Apr 2021to 30 Sep 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Albuminuria defined as urinary albumin:creatinine ratio ≥ 25 mg/g (or protein:creatinine ratio ≥ 30 mg/g) or albuminuria > 30 mg/24h
- eGFR > 25 and < 75 ml/minute 1.73m2
- BMI between 19 kg/m2 and 30 kg/m2
- Treatment with an ACE inhibitor and/or ARB at the maximum tolerated (for the individual subject) dose. The maximum tolerated dose for an individual subject may be less than the maximum labeled dose or may be zero if the medical reason is documented.
- Mean systolic and diastolic blood pressure (determined as the average of three replicates) must be < 180/90mmHg
- Pre-menopausal women of child-bearing potential 1 must have a negative pregnancy test performed before the inclusion in the study V e r s i o n 6 . 0 - P a g . 10 | 32
Show all 15Show fewer
- Willingness to participate in the study (signed informed consent)
- IN PARTICIPANTS WITH Type 2 Diabetes
- Clinical diagnosis of T2DM for at least 1 year
- Hemoglobin A1c (HbA1c) value of < 9.5%
- Patients treated only with metformin and/or repaglinide
- A diagnosis of Diabetic Nephropathy at renal biopsy made not more than 6 months before the screening visit (only for the subgroup of patients candidated to the second kidney biopsy)
- Proteinuria > 1g/24h (only for the subgroup of patients candidated to the second kidney biopsy)
- Hemoglobin A1c (HbA1c) value of > 6.5% (only for patients candidated to the second kidney biopsy) In PARTICIPANTS Without Type 2 Diabetes
- diagnosis of hypertension for at least 5 years
Who cannot join
- Type 1 Diabetes
- Hemoglobin A1c (HbA1c) value of > 9.5% during the Screening period (based on central laboratory measurement).
- The need for an adjunctive drugs on top on metformin and repaglinide
- Hemoglobin A1c (HbA1c) value of < 6.5% only for patients candidated to the second kidney biopsy
- Estimated glomerular filtration rate < 25 or > 75 ml/min/1.73m2 (according to the CKD-EPI) at screening
- Untreated urinary or genital infection at screening and follow-up
Show all 25Show fewer
- Clear signs of volume depletion
- Symptomatic hypotension, or systolic blood pressure < 90 or non-controlled hypertension
- History of alcohol or drug abuse, anuria, dialysis, or acute kidney injury/acute renal failure in the 3 months prior to Screening Period
- Heart, liver or kidney transplant V e r s i o n 6 . 0 - P a g . 11 | 32
- Acute coronary syndrome, stroke, or transient ischemic attack within 3 months prior to informed consent
- Liver disease, defined by serum levels of alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase above 3 x upper limit of normal (ULN) during screening
- Planned cardiac surgery or angioplasty within 3 months
- Cancer or medical history of cancer (except for basal cell carcinoma) within the last 5 years
- Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at time of screening leading to unstable body weight (e.g. surgery, aggressive diet regimen, etc.)
- SGLT2i treatment in the 10 weeks before the Screening Period
- Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent
- Any uncontrolled endocrine disorder except T2DM
- Women who are pregnant or breastfeeding
- Pre-menopausal women of child bearing potential who are not willing to employ effective contraception according to 2007 CTFG Recommendations related to contraception and pregnancy testing in clinical trials from screening for all the duration of the study
- Patients with a known hypersensitivity to Dapagliflozin or other SGLT2- inhibitors, including hypersensitivity to excipients (e.g. lactose)
- History of pancreatitis, or pancreatic surgery, diabetic ketoacidosis
- Prior lower extremity amputation or current threat of amputation (eg, lower extremity ulcer and peripheral artery disease)
- History of severe hypoglycaemia and hypoglycaemia unawareness.
- Contraindication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Randomized, Controlled Study to Evaluate the Effects of a Six-month Treatment With Renal Glucose Transport Inhibitor (SGLT2i) Drugs on Markers of Senescence, Inflammation and Tubulointerstitial Damage in the Kidney of Patients With Chronic Kidney Disease With or Without Type 2 Diabetes
This is a single-center, double blind, randomized, parallel-arms study designed to investigate the effects of a six-month treatment with the SGLT2i dapagliflozin on markers of kidney senescence, inflammation and tubulointerstitial damage compared to placebo. These mechanisms of renal damage will be investigated in proximal tubular epithelial cells (PTECs) isolated from urine from patients with CKD with or without T2DM and in renal biopsy specimens in a subgroup of patients with diabetic kidney disease.
Read the detailed description
In the run-in phase, clinical parameters will be optimized by the use of metformin/repaglinide and or RAAS-I on the basis of the presence/absence of a diagnosis of diabetes. Subsequently, patients will be randomly assigned to start with standard therapy and placebo or dapagliflozin at the dose of 10 mg and will continue the assigned treatment for 24 weeks in double-blind and with dapagliflozin at the dose of 10 mg for an additional 48 weeks in open-label/Extended treatment.
Urine samples will be collected at T0, T1, T2, T3 and T4 and used as a source of PTECs in order to study the expression of mediators of senescence, fibrosis and inflammation in the kidney. 24-hour ambulatory blood pressure monitoring, Bio-impedancemetry will be evaluated at T0, and T2 and the assessment of tubular oxygen consumption by MRI with BOLD method will be performed at baseline (T0) and after 12 weeks of treatment (T1). This timeline seems to be more appropriate for investigating chances in functional parameters such as blood pressure behaviour, distribution of body water and tubular oxigen consumption.
Based on health claims data published in scientific journals, the treatment extension with Dapaglifozin will be proposed to patients of both arms of the Study at the end of 24 Weeks of treatment (T2) for additional 48 Weeks (T3, T4).
- Being tested
- Dapagliflozin 10mg Tab, Placebo
- Keywords
- gliflozine, senescence, BOLD MRI, Blood pressure variability
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Dapagliflozin will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject.
Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide
PlaceboDrug
Placebo will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject.
Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes Dapagliflozin 10 mg | Active comparator | Patients with Type 2 Diabetes allocated to Dapagliflozin 10 mg Receives: Drug: Dapagliflozin 10mg Tab |
| Type 2 Diabetes Placebo | Placebo comparator | Patients with Type 2 Diabetes allocated to Placebo Receives: Drug: Placebo |
| Without Diabetes Dapagliflozin 10 mg | Active comparator | Patients without Type 2 Diabetes allocated to Dapagliflozin 10 mg Receives: Drug: Dapagliflozin 10mg Tab |
| Without Diabetes Placebo | Placebo comparator | Patients without Type 2 Diabetes allocated to Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary proximal tubule cells changes in protein expression of inflammatory genes such as p16ink4a, TLR-4, phospho-p65, DKK3, Myostatin, TGFβ, SMAD 2,3 and MAPK pathways.
Measured: baseline and every 3 months up to 18 month
Urinary proximal tubule cells changes in genes such as type IV collagen fibronectin, TGF-β, TNF receptor 1, EMF cadherin production, NF-kB, MCP-1 , DKK3, myostatin and Activin A
Measured: baseline and every 3 months up to 18 month
Biopsy changes in the expression and location of senescence markers by immunohistochemistry
In the first six patients with T2DM, proteinuria > 1 g/day and biopsy proven diabetic kidney disese allocated to the treatment with dapagliflozin, we will investigate the following changes in expression and location of p16inkA, SA-beta-galactosidase, TNF receptor 1, EMF cadherin NF-kB.
Measured: Baseline and after 6 month
Secondary outcomes (5)
Changes in BOLD MRI
Changes in global and segmental renal oxygenation estimated by BOLD MRI (changes in R2* value defined as 1/T2*) at 12 and 24 weeks
Measured: Baseline and after 3 month
Urinary markers of interstitial fibrosis
Changes in urinary markers of a proxy of interstitial fibrosis in patients with CKD (Mir 20)
Measured: Baseline and every 3 months up to 18 month
Changes in urinary albumin excretion
Changes in urinary albumin excretion
Measured: Baseline and every 3 months up to 18 month
Changes in eGFR
decrease of eGFR ml/min > 30%
Measured: Baseline and every 3 months up to 18 month
Outcomes of blood presssure control
changes in blood pressure values and in the need of antihypertensive drugs
Measured: Baseline and every 6 months up to 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start13 Apr 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation to treatment group will be done by stratified randomization for diabetics and non-diabetics. The randomization list will be generated with a designed computer program.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Francesca Viazzi, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998837
- Sponsor's protocol ID
- D169AL00005
- Acronym
- GLUTREPRO
- Status last verified
- Feb 2025
- First submitted
- 16 Apr 2023
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Russo E, Cappadona F, Maccio L, Di Vincenzo J, Piaggio M, Verzola D, Chirco G, Garibotto G, Esposito P, Viazzi F. Dapagliflozin Reduces Ambulatory Arterial Stiffness Index in CKD Patients with and Without Diabetes Independently of Blood Pressure Control: Results from the GLUcose Transport and Renal PROtection in Chronic Kidney Disease (GLUTREPRO) Trial. High Blood Press Cardiovasc Prev. 2026 Jan;33(1):117-126. doi: 10.1007/s40292-025-00764-3. Epub 2025 Dec 9.
PubMed 41366613Russo E, Venturelli E, Di Vincenzo J, Maccio L, Esposito P, Cappadona F, Ferrazzi G, Grillo R, Damasio MB, Garibotto G, Viazzi F. Dapagliflozin Mitigates Medullary Hypoxia in CKD Patients: Analysis of Blood Oxygenation Level-Dependent Magnetic Resonance Imaging Renal Data from the Randomized Glucose Transport and Renal Protection in CKD Trial. Kidney360. 2026 Mar 1;7(3):535-546. doi: 10.34067/KID.0000001015. Epub 2025 Nov 12.
PubMed 41223002
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Randomized, Controlled Study to Evaluate the Effects of a Six-month Treatment With Renal Glucose Transport Inhibitor (SGLT2i) Drugs on Markers of Senescence, Inflammation and Tubulointerstitial Damage in the Kidney of Patients With Chronic Kidney Disease With or Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05998837
- Acronym / sponsor ID
- GLUTREPRO / D169AL00005
- Keywords
- gliflozine, senescence, BOLD MRI, Blood pressure variability
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 21 Aug 2023 (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.
This is a single-center, double blind, randomized, parallel-arms study designed to investigate the effects of a six-month treatment with the SGLT2i dapagliflozin on markers of kidney senescence, inflammation and tubulointerstitial damage compared to placebo. These mechanisms of renal damage will be investigated in proximal tubular epithelial cells (PTECs) isolated from urine from patients with CKD with or without T2DM and in renal biopsy specimens in a subgroup of patients with diabetic kidney disease.
Detailed description
In the run-in phase, clinical parameters will be optimized by the use of metformin/repaglinide and or RAAS-I on the basis of the presence/absence of a diagnosis of diabetes. Subsequently, patients will be randomly assigned to start with standard therapy and placebo or dapagliflozin at the dose of 10 mg and will continue the assigned treatment for 24 weeks in double-blind and with dapagliflozin at the dose of 10 mg for an additional 48 weeks in open-label/Extended treatment.
Urine samples will be collected at T0, T1, T2, T3 and T4 and used as a source of PTECs in order to study the expression of mediators of senescence, fibrosis and inflammation in the kidney. 24-hour ambulatory blood pressure monitoring, Bio-impedancemetry will be evaluated at T0, and T2 and the assessment of tubular oxygen consumption by MRI with BOLD method will be performed at baseline (T0) and after 12 weeks of treatment (T1). This timeline seems to be more appropriate for investigating chances in functional parameters such as blood pressure behaviour, distribution of body water and tubular oxigen consumption.
Based on health claims data published in scientific journals, the treatment extension with Dapaglifozin will be proposed to patients of both arms of the Study at the end of 24 Weeks of treatment (T2) for additional 48 Weeks (T3, T4).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Allocation to treatment group will be done by stratified randomization for diabetics and non-diabetics. The randomization list will be generated with a designed computer program.
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes Dapagliflozin 10 mg | Active comparator | Drug: Dapagliflozin 10mg TabPatients with Type 2 Diabetes allocated to Dapagliflozin 10 mg |
| Type 2 Diabetes Placebo | Placebo comparator | Drug: PlaceboPatients with Type 2 Diabetes allocated to Placebo |
| Without Diabetes Dapagliflozin 10 mg | Active comparator | Drug: Dapagliflozin 10mg TabPatients without Type 2 Diabetes allocated to Dapagliflozin 10 mg |
| Without Diabetes Placebo | Placebo comparator | Drug: PlaceboPatients without Type 2 Diabetes allocated to Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Albuminuria defined as urinary albumin:creatinine ratio ≥ 25 mg/g (or protein:creatinine ratio ≥ 30 mg/g) or albuminuria > 30 mg/24h
- eGFR > 25 and < 75 ml/minute 1.73m2
- BMI between 19 kg/m2 and 30 kg/m2
- Treatment with an ACE inhibitor and/or ARB at the maximum tolerated (for the individual subject) dose. The maximum tolerated dose for an individual subject may be less than the maximum labeled dose or may be zero if the medical reason is documented.
- Mean systolic and diastolic blood pressure (determined as the average of three replicates) must be < 180/90mmHg
Key exclusion criteria (25 listed)
- Type 1 Diabetes
- Hemoglobin A1c (HbA1c) value of > 9.5% during the Screening period (based on central laboratory measurement).
- The need for an adjunctive drugs on top on metformin and repaglinide
- Hemoglobin A1c (HbA1c) value of < 6.5% only for patients candidated to the second kidney biopsy
- Estimated glomerular filtration rate < 25 or > 75 ml/min/1.73m2 (according to the CKD-EPI) at screening
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 |
|---|---|---|
| Dapagliflozin 10mg TabDapagliflozin will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject. Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide | Drug | Type 2 Diabetes Dapagliflozin 10 mg, Without Diabetes Dapagliflozin 10 mg |
| PlaceboPlacebo will be add on RAAS-i titrated with the aim to reach optimal blood pressure control as defined by European Society of Hypertension (i.e., 120-130/70-80 mmHg) in all subject. Prior to randomization all the patient with Type 2 Diabetes must have undergone at least 4 weeks of therapy with metformin and/or repaglinide | Drug | Type 2 Diabetes Placebo, Without Diabetes Placebo |
Primary outcome
Urinary proximal tubule cells changes in protein expression of inflammatory genes such as p16ink4a, TLR-4, phospho-p65, DKK3, Myostatin, TGFβ, SMAD 2,3 and MAPK pathways.
Time frame: baseline and every 3 months up to 18 month
Urinary proximal tubule cells changes in genes such as type IV collagen fibronectin, TGF-β, TNF receptor 1, EMF cadherin production, NF-kB, MCP-1 , DKK3, myostatin and Activin A
Time frame: baseline and every 3 months up to 18 month
Biopsy changes in the expression and location of senescence markers by immunohistochemistry
Time frame: Baseline and after 6 month
In the first six patients with T2DM, proteinuria > 1 g/day and biopsy proven diabetic kidney disese allocated to the treatment with dapagliflozin, we will investigate the following changes in expression and location of p16inkA, SA-beta-galactosidase, TNF receptor 1, EMF cadherin NF-kB.
5 secondary outcomes
Changes in BOLD MRI
Time frame: Baseline and after 3 month
Urinary markers of interstitial fibrosis
Time frame: Baseline and every 3 months up to 18 month
Changes in urinary albumin excretion
Time frame: Baseline and every 3 months up to 18 month
Changes in eGFR
Time frame: Baseline and every 3 months up to 18 month
Outcomes of blood presssure control
Time frame: Baseline and every 6 months up to 18 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 41366613Russo E, Cappadona F, Maccio L, Di Vincenzo J, Piaggio M, Verzola D, Chirco G, Garibotto G, Esposito P, Viazzi F. Dapagliflozin Reduces Ambulatory Arterial Stiffness Index in CKD Patients with and Without Diabetes Independently of Blood Pressure Control: Results from the GLUcose Transport and Renal PROtection in Chronic Kidney Disease (GLUTREPRO) Trial. High Blood Press Cardiovasc Prev. 2026 Jan;33(1):117-126. doi: 10.1007/s40292-025-00764-3. Epub 2025 Dec 9.
- Derived from this study: PubMed 41223002Russo E, Venturelli E, Di Vincenzo J, Maccio L, Esposito P, Cappadona F, Ferrazzi G, Grillo R, Damasio MB, Garibotto G, Viazzi F. Dapagliflozin Mitigates Medullary Hypoxia in CKD Patients: Analysis of Blood Oxygenation Level-Dependent Magnetic Resonance Imaging Renal Data from the Randomized Glucose Transport and Renal Protection in CKD Trial. Kidney360. 2026 Mar 1;7(3):535-546. doi: 10.34067/KID.0000001015. Epub 2025 Nov 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapagliflozin 10mg Tab in people with Chronic Kidney Disease and Diabetes Mellitus, Type 2, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. 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 Italy. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary proximal tubule cells changes in protein expression of inflammatory genes such as p16ink4a, TLR-4, phospho-p65, DKK3, Myostatin, TGFβ, SMAD 2,3 and MAPK pathways. (time frame: baseline and every 3 months up to 18 month). The study lists 3 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 NCT05998837, which also lists 2 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 28 Mar 2025.