Peritoneal Dialysis ComplicationNCT06398977

Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients

A study testing Dapagliflozin in people with Peritoneal Dialysis Complication and Renal Function Aggravated, run by Sichuan Academy of Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Peritoneal Dialysis Complication, Renal Function Aggravated, Sodium-glucose Co-transporter-2 Inhibitors
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteChina
Study dates: 11 Mar 2024to 31 Dec 2026
Phase: Interventional
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with PD duration between 1 month and 3 months.
Patients aged between 18 and 75 years.
Voluntary signing of informed consent.
Stable use of a maximum tolerated dose of RAAS inhibitors for one month if hypertension is present.
Daily urine output ≥ 400ml/day.
Stable PD prescription for one month.

Who cannot join

Pregnant and lactating women.
Patients with type 1 diabetes mellitus.
Patients with type 2 diabetes mellitus who have experienced diabetic ketoacidosis in the past.
Patients with chronic liver disease, including non-alcoholic fatty liver disease, cirrhosis, ALT > 120 IU/L, and other clinically confirmed severe liver diseases.
Patients with more than 2 episodes of urinary tract infection in the past six months.
Patients with severe allergic reactions (rash or angioedema) to Dapagliflozin.

Show all 14Show fewer

Patients using the following medications: rifampicin, phenytoin.
Patients with malignant tumors.
Patients who developed peritonitis within one month.
Patients undergoing combined hemodialysis treatment.
Patients with a willingness for kidney transplantation within six months.
Patients with a history of pancreatitis or pancreatic transplantation.
Patients who experienced acute coronary syndrome or cerebrovascular events within one month.
Hemoglobin level less than 90g/L.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jin Chen, MD contact

0086-28-87393195

jessicakxcj@uestc.edu.cn

Xinyi Tan, Master contact

0086-28-87398195

China1 site, 1 recruiting

Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospita
Chengdu, Sichuan, 610000
Jin Chen, MD, 0086-28-87393195, jessicakxcj@uestc.edu.cn
Xin Yi Tan, Master, 0086-28-87393195
Recruiting

Other trials in China

About this study

Official title: Dapagliflozin Delays the Loss of Residual Renal Function in Patients Undergoing Peritoneal Dialysis: A Single-Center Randomized Open-Label Study

This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.

Read the detailed description

Residual renal function (RRF) plays the role of removing water and body metabolic wastes, as well as secretion of erythropoietin and promotion of vitamin D absorption, which can maintain the stability of the internal environment. Several studies have demonstrated that preservation of RRF in PD patients reduces complications, increases dialysis adequacy and decreases mortality. In addition, residual renal function is an important factor in the technique survival. Methods to protect residual renal function in peritoneal dialysis patients include controlling blood pressure, controlling blood glucose, adjusting dialysis prescription, and using renin-angiotensin inhibitors. However, the above methods currently play only a limited role.

Sodium-dependent glucose transporters 2 (SGLT2) inhibitors are drugs used in the treatment of type 2 diabetes mellitus that inhibit the reabsorption of glucose by the kidneys, causing glucose to be excreted in the urine and lowering blood glucose. Studies have demonstrated that SGLT2 inhibitors also attenuate renal tubular injury, reduce the excretion of proteinuria, and have a protective effect on RRF in non-dialysis patients with chronic kidney disease. However, there are no clinical studies demonstrating whether the use of SGLT2 inhibitors in peritoneal dialysis patients is renal protective.

In light of this, this study introduces dagliflozin orally to PD patients over a 24-week period to explore its protective effects on RRF and cardiac health, with participants being randomly divided into a dagliflozin group and a control group. The results of this study will be beneficial in informing the clinical practice of SGLT2 inhibitors and improving dialysis outcomes in PD patients.

Conditions: Peritoneal Dialysis Complication, Renal Function Aggravated, Sodium-glucose Co-transporter-2 Inhibitors
Being tested: Dapagliflozin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DapagliflozinDrug
Also called dagliflozin
Dapagliflozin10MG, PO once daily

Study groups in NCT06398977
Study group	Role	What they receive
Dagliflozin group	Active comparator	Patients in this group were treated with dagliflozin 10 mg, oral once daily, for 24 weeks, in addition to receiving basic treatments such as peritoneal dialysis and antihypertensive and hypoglycemic therapy. Receives: Drug: Dapagliflozin
Control group	No intervention	This group of patients received peritoneal dialysis and basic treatments such as antihypertensive and hypoglycemic therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in 24 urine volume
The total amount of urine excreted over a 24-hour period. The patient's urine output was measured continuously for 2 days, and the average volume was calculated, with the unit being millilitres.
Measured: Baseline, 2,12 and 24 weeks.

Secondary outcomes (17)

Change in renal Kt/Vurea
A measure used in peritoneal dialysis therapy to assess adequacy, representing the renal clearance of urea (K) over time (t) normalized to body water volume (V).
Measured: Baseline, 2, 12 and 24 weeks.
Change in BNP（Brain natriuretic peptide）
Concentration of serum BNP which could assess cardiac function.
Measured: Baseline, 2, 12 and 24 weeks.
Change in EF%
The ejection fraction (EF%) value was measured using echocardiography by the hospital's ultrasound department, with all ultrasound examinations conducted by two attending physicians.
Measured: Baseline and 24 weeks.
Change in ultrafiltration
The total amount of water removed from the body through dialysis each day.
Measured: Baseline, 2, 12 and 24 weeks.
Change in HbA1C （Hemoglobin A1C) rate
Rate of Glycated Hemoglobin (HbA1C) as an Indicator of Long-term Glycemic Control in Serum.
Measured: Baseline, 12 and 24 weeks.
Change in serum sodium concentration
Concentration of sodium ions in the blood.
Measured: Baseline, 2, 12 and 24 weeks.
Change in urinary sodium concentration
The concentration of sodium in the 24-hour urine.
Measured: Baseline, 2, 12 and 24 weeks.
Change in dialysate sodium concentration
The concentration of sodium in the 24-hour dialysate.
Measured: Baseline, 2, 12 and 24 weeks.
Change in urinary glucose concentration
The concentration of glucose in the 24-hour urine.
Measured: Baseline, 2, 12 and 24 weeks.
Change in blood pressure
The bloody pressure of the patient in the morning.
Measured: Baseline, 2, 12 and 24 weeks.
Change in body weight
The weight of the patient is measured on an empty stomach without containing dialysate.
Measured: Baseline, 2, 12 and 24 weeks.
Episodes of peritonitis
The number of episodes of a patient during the trial.
Measured: 24 weeks.
Hospitalization
The number of patients admitted to hospital during the trial.
Measured: 24 weeks.
Time of dropout PD
The point in time at which a patient either discontinues PD treatment or experiences death during the trail.
Measured: 24 weeks.
Concentration in Dapagliflozin 3-O-Glucuronide in urine
Concentration of Dapagliflozin 3-O-Glucuronide in urine indicating Dapagliflozin metabolic activity.
Measured: Baseline, 2, 12 and 24 weeks.
Concentration in Dapagliflozin 3-O-Glucuronide in dialysate
Concentration of Dapagliflozin 3-O-Glucuronide in dialysate reflecting Dapagliflozin metabolism.
Measured: Baseline, 2, 12 and 24 weeks.
concentration of Dapagliflozin 3-O-Glucuronide in serum
Concentration of Dapagliflozin 3-O-Glucuronide in serum reflecting Dapagliflozin metabolism.
Measured: Baseline, 2, 12 and 24 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 202431 Dec 2026

First posted3 May 2024
Study start11 Mar 2024
Primary completion30 Jun 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Peritoneal Dialysis ComplicationStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06398977
Sponsor's protocol ID: DDLR-PD
Status last verified: Apr 2024
First submitted: 16 Apr 2024
Last updated: 3 May 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

van der Wal WM, Noordzij M, Dekker FW, Boeschoten EW, Krediet RT, Korevaar JC, Geskus RB; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group (NECOSAD). Full loss of residual renal function causes higher mortality in dialysis patients; findings from a marginal structural model. Nephrol Dial Transplant. 2011 Sep;26(9):2978-83. doi: 10.1093/ndt/gfq856. Epub 2011 Feb 11.
PubMed 21317411
Bargman JM, Thorpe KE, Churchill DN. Relative contribution of residual renal function and peritoneal clearance to adequacy of dialysis: a reanalysis of the CANUSA study. J Am Soc Nephrol. 2001 Oct;12(10):2158-2162. doi: 10.1681/ASN.V12102158.
PubMed 11562415
Bello AK, Okpechi IG, Osman MA, Cho Y, Cullis B, Htay H, Jha V, Makusidi MA, McCulloch M, Shah N, Wainstein M, Johnson DW. Epidemiology of peritoneal dialysis outcomes. Nat Rev Nephrol. 2022 Dec;18(12):779-793. doi: 10.1038/s41581-022-00623-7. Epub 2022 Sep 16.
PubMed 36114414
Parving H-H, Lambers-Heerspink H, de Zeeuw D. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Nov 3;375(18):1800-1. doi: 10.1056/NEJMc1611290. No abstract available.
PubMed 28106974
Persson F, Rossing P, Vart P, Chertow GM, Hou FF, Jongs N, McMurray JJV, Correa-Rotter R, Bajaj HS, Stefansson BV, Toto RD, Langkilde AM, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial. Diabetes Care. 2021 Aug;44(8):1894-1897. doi: 10.2337/dc21-0300. Epub 2021 Jun 28.
PubMed 34183431
Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Furtado RHM, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS. Comparison of the Effects of Glucagon-Like Peptide Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Major Adverse Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus. Circulation. 2019 Apr 23;139(17):2022-2031. doi: 10.1161/CIRCULATIONAHA.118.038868.
PubMed 30786725
Birkeland KI, Jorgensen ME, Carstensen B, Persson F, Gulseth HL, Thuresson M, Fenici P, Nathanson D, Nystrom T, Eriksson JW, Bodegard J, Norhammar A. Cardiovascular mortality and morbidity in patients with type 2 diabetes following initiation of sodium-glucose co-transporter-2 inhibitors versus other glucose-lowering drugs (CVD-REAL Nordic): a multinational observational analysis. Lancet Diabetes Endocrinol. 2017 Sep;5(9):709-717. doi: 10.1016/S2213-8587(17)30258-9. Epub 2017 Aug 3.
PubMed 28781064
Persson F, Nystrom T, Jorgensen ME, Carstensen B, Gulseth HL, Thuresson M, Fenici P, Nathanson D, Eriksson JW, Norhammar A, Bodegard J, Birkeland KI. Dapagliflozin is associated with lower risk of cardiovascular events and all-cause mortality in people with type 2 diabetes (CVD-REAL Nordic) when compared with dipeptidyl peptidase-4 inhibitor therapy: A multinational observational study. Diabetes Obes Metab. 2018 Feb;20(2):344-351. doi: 10.1111/dom.13077. Epub 2017 Sep 8.
PubMed 28771923
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
PubMed 35379503
Lui SL, Yung S, Yim A, Wong KM, Tong KL, Wong KS, Li CS, Au TC, Lo WK, Ho YW, Ng F, Tang C, Chan TM. A combination of biocompatible peritoneal dialysis solutions and residual renal function, peritoneal transport, and inflammation markers: a randomized clinical trial. Am J Kidney Dis. 2012 Dec;60(6):966-75. doi: 10.1053/j.ajkd.2012.05.018. Epub 2012 Jul 25.
PubMed 22835900
Li T, Wilcox CS, Lipkowitz MS, Gordon-Cappitelli J, Dragoi S. Rationale and Strategies for Preserving Residual Kidney Function in Dialysis Patients. Am J Nephrol. 2019;50(6):411-421. doi: 10.1159/000503805. Epub 2019 Oct 18.
PubMed 31630148
Mosenzon O, Wiviott SD, Cahn A, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Heerspink HJL, Zelniker TA, Dwyer JP, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Kato ET, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):606-617. doi: 10.1016/S2213-8587(19)30180-9. Epub 2019 Jun 10.
PubMed 31196815
Barreto J, Borges C, Rodrigues TB, Jesus DC, Campos-Staffico AM, Nadruz W, Luiz da Costa J, Bueno de Oliveira R, Sposito AC. Pharmacokinetic Properties of Dapagliflozin in Hemodialysis and Peritoneal Dialysis Patients. Clin J Am Soc Nephrol. 2023 Aug 1;18(8):1051-1058. doi: 10.2215/CJN.0000000000000196. Epub 2023 May 25.
PubMed 37227937

Interested in taking part?

Jin Chen, MD

0086-28-87393195

jessicakxcj@uestc.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
Days-Off Versus Daily Initial Peritoneal Dialysis Prescription
Kidney Failure
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
RecruitingPhase 2
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All Peritoneal Dialysis Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dapagliflozin Delays the Loss of Residual Renal Function in Patients Undergoing Peritoneal Dialysis: A Single-Center Randomized Open-Label Study
ClinicalTrials.gov ID: NCT06398977
Acronym / sponsor ID: DDLR-PD
Conditions: Peritoneal Dialysis Complication, Renal Function Aggravated, Sodium-glucose Co-transporter-2 Inhibitors
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 70 participants (estimated)
Lead sponsor: Sichuan Academy of Medical SciencesUniversity, hospital or other
Study start: 11 Mar 2024 (actual)
Primary completion: 30 Jun 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 3 May 2024 (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 study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dagliflozin group	Active comparator	Drug: DapagliflozinPatients in this group were treated with dagliflozin 10 mg, oral once daily, for 24 weeks, in addition to receiving basic treatments such as peritoneal dialysis and antihypertensive and hypoglycemic therapy.
Control group	No intervention	–This group of patients received peritoneal dialysis and basic treatments such as antihypertensive and hypoglycemic therapy.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients with PD duration between 1 month and 3 months.
Patients aged between 18 and 75 years.
Voluntary signing of informed consent.
Stable use of a maximum tolerated dose of RAAS inhibitors for one month if hypertension is present.
Daily urine output ≥ 400ml/day.

Key exclusion criteria (14 listed)

Pregnant and lactating women.
Patients with type 1 diabetes mellitus.
Patients with type 2 diabetes mellitus who have experienced diabetic ketoacidosis in the past.
Patients with chronic liver disease, including non-alcoholic fatty liver disease, cirrhosis, ALT > 120 IU/L, and other clinically confirmed severe liver diseases.
Patients with more than 2 episodes of urinary tract infection in the past six months.

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
DapagliflozinAlso: dagliflozinDapagliflozin10MG, PO once daily	Drug	Dagliflozin group

Primary outcome

Change in 24 urine volume
Time frame: Baseline, 2,12 and 24 weeks.
The total amount of urine excreted over a 24-hour period. The patient's urine output was measured continuously for 2 days, and the average volume was calculated, with the unit being millilitres.

17 secondary outcomes

Change in renal Kt/Vurea
Time frame: Baseline, 2, 12 and 24 weeks.
Change in BNP（Brain natriuretic peptide）
Time frame: Baseline, 2, 12 and 24 weeks.
Change in EF%
Time frame: Baseline and 24 weeks.
Change in ultrafiltration
Time frame: Baseline, 2, 12 and 24 weeks.
Change in HbA1C （Hemoglobin A1C) rate
Time frame: Baseline, 12 and 24 weeks.
Change in serum sodium concentration
Time frame: Baseline, 2, 12 and 24 weeks.
Change in urinary sodium concentration
Time frame: Baseline, 2, 12 and 24 weeks.
Change in dialysate sodium concentration
Time frame: Baseline, 2, 12 and 24 weeks.
Change in urinary glucose concentration
Time frame: Baseline, 2, 12 and 24 weeks.
Change in blood pressure
Time frame: Baseline, 2, 12 and 24 weeks.
Change in body weight
Time frame: Baseline, 2, 12 and 24 weeks.
Episodes of peritonitis
Time frame: 24 weeks.
Hospitalization
Time frame: 24 weeks.
Time of dropout PD
Time frame: 24 weeks.
Concentration in Dapagliflozin 3-O-Glucuronide in urine
Time frame: Baseline, 2, 12 and 24 weeks.
Concentration in Dapagliflozin 3-O-Glucuronide in dialysate
Time frame: Baseline, 2, 12 and 24 weeks.
concentration of Dapagliflozin 3-O-Glucuronide in serum
Time frame: Baseline, 2, 12 and 24 weeks.

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 3 May 2024.
Background: PubMed 21317411van der Wal WM, Noordzij M, Dekker FW, Boeschoten EW, Krediet RT, Korevaar JC, Geskus RB; Netherlands Cooperative Study on the Adequacy of Dialysis Study Group (NECOSAD). Full loss of residual renal function causes higher mortality in dialysis patients; findings from a marginal structural model. Nephrol Dial Transplant. 2011 Sep;26(9):2978-83. doi: 10.1093/ndt/gfq856. Epub 2011 Feb 11.
Background: PubMed 11562415Bargman JM, Thorpe KE, Churchill DN. Relative contribution of residual renal function and peritoneal clearance to adequacy of dialysis: a reanalysis of the CANUSA study. J Am Soc Nephrol. 2001 Oct;12(10):2158-2162. doi: 10.1681/ASN.V12102158.
Background: PubMed 36114414Bello AK, Okpechi IG, Osman MA, Cho Y, Cullis B, Htay H, Jha V, Makusidi MA, McCulloch M, Shah N, Wainstein M, Johnson DW. Epidemiology of peritoneal dialysis outcomes. Nat Rev Nephrol. 2022 Dec;18(12):779-793. doi: 10.1038/s41581-022-00623-7. Epub 2022 Sep 16.
Background: PubMed 28106974Parving H-H, Lambers-Heerspink H, de Zeeuw D. Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes. N Engl J Med. 2016 Nov 3;375(18):1800-1. doi: 10.1056/NEJMc1611290. No abstract available.
Background: PubMed 34183431Persson F, Rossing P, Vart P, Chertow GM, Hou FF, Jongs N, McMurray JJV, Correa-Rotter R, Bajaj HS, Stefansson BV, Toto RD, Langkilde AM, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial. Diabetes Care. 2021 Aug;44(8):1894-1897. doi: 10.2337/dc21-0300. Epub 2021 Jun 28.
Background: PubMed 30786725Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Furtado RHM, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS. Comparison of the Effects of Glucagon-Like Peptide Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Major Adverse Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus. Circulation. 2019 Apr 23;139(17):2022-2031. doi: 10.1161/CIRCULATIONAHA.118.038868.
Background: PubMed 28781064Birkeland KI, Jorgensen ME, Carstensen B, Persson F, Gulseth HL, Thuresson M, Fenici P, Nathanson D, Nystrom T, Eriksson JW, Bodegard J, Norhammar A. Cardiovascular mortality and morbidity in patients with type 2 diabetes following initiation of sodium-glucose co-transporter-2 inhibitors versus other glucose-lowering drugs (CVD-REAL Nordic): a multinational observational analysis. Lancet Diabetes Endocrinol. 2017 Sep;5(9):709-717. doi: 10.1016/S2213-8587(17)30258-9. Epub 2017 Aug 3.
Background: PubMed 28771923Persson F, Nystrom T, Jorgensen ME, Carstensen B, Gulseth HL, Thuresson M, Fenici P, Nathanson D, Eriksson JW, Norhammar A, Bodegard J, Birkeland KI. Dapagliflozin is associated with lower risk of cardiovascular events and all-cause mortality in people with type 2 diabetes (CVD-REAL Nordic) when compared with dipeptidyl peptidase-4 inhibitor therapy: A multinational observational study. Diabetes Obes Metab. 2018 Feb;20(2):344-351. doi: 10.1111/dom.13077. Epub 2017 Sep 8.
Background: PubMed 35379503Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
Background: PubMed 22835900Lui SL, Yung S, Yim A, Wong KM, Tong KL, Wong KS, Li CS, Au TC, Lo WK, Ho YW, Ng F, Tang C, Chan TM. A combination of biocompatible peritoneal dialysis solutions and residual renal function, peritoneal transport, and inflammation markers: a randomized clinical trial. Am J Kidney Dis. 2012 Dec;60(6):966-75. doi: 10.1053/j.ajkd.2012.05.018. Epub 2012 Jul 25.
Results publication: PubMed 31630148Li T, Wilcox CS, Lipkowitz MS, Gordon-Cappitelli J, Dragoi S. Rationale and Strategies for Preserving Residual Kidney Function in Dialysis Patients. Am J Nephrol. 2019;50(6):411-421. doi: 10.1159/000503805. Epub 2019 Oct 18.
Results publication: PubMed 31196815Mosenzon O, Wiviott SD, Cahn A, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Heerspink HJL, Zelniker TA, Dwyer JP, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Kato ET, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):606-617. doi: 10.1016/S2213-8587(19)30180-9. Epub 2019 Jun 10.
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.

Jin Chen, MD contact

0086-28-87393195

jessicakxcj@uestc.edu.cn

Xinyi Tan, Master contact

0086-28-87398195

Jin Chen, MD principal investigator

Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dapagliflozin in people with Peritoneal Dialysis Complication and Renal Function Aggravated, run by Sichuan Academy of Medical Sciences at 1 site in China.

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 6 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 May 2024. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 Jin Chen, MD (0086-28-87393195, jessicakxcj@uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 24 urine volume (time frame: Baseline, 2,12 and 24 weeks.). 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 NCT06398977, which also lists 13 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 3 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.