Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients

NCT06398977 | Recruiting

• 1 other identifier: DDLR-PD
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peritoneal Dialysis Complication; Renal Function Aggravated; Sodium-glucose Co-transporter-2 Inhibitors

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 2,12 and 24 weeks.

Secondary Outcomes (17)

• Change in renal Kt/Vurea

  Baseline, 2, 12 and 24 weeks.

• Change in BNP（Brain natriuretic peptide）

  Baseline, 2, 12 and 24 weeks.

• Change in EF%

  Baseline and 24 weeks.

• Change in ultrafiltration

  Baseline, 2, 12 and 24 weeks.

• Change in HbA1C （Hemoglobin A1C) rate

  Baseline, 12 and 24 weeks.

Study Arms (2)

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.

Drug: Dapagliflozin

Control group

NO INTERVENTION

This group of patients received peritoneal dialysis and basic treatments such as antihypertensive and hypoglycemic therapy.

Interventions

Dapagliflozin DRUG

Dapagliflozin10MG, PO once daily

Also known as: dagliflozin

Dagliflozin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sichuan Academy of Medical Sciences: lead

Study Sites (1)

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

Chengdu, Sichuan, 610000, China

RECRUITING

Related Publications (13)

• 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.

  PMID: 21317411 BACKGROUND

• 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.

  PMID: 11562415 BACKGROUND

• 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.

  PMID: 36114414 BACKGROUND

• 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.

  PMID: 28106974 BACKGROUND

• 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.

  PMID: 34183431 BACKGROUND

• 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.

  PMID: 30786725 BACKGROUND

• 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.

  PMID: 28781064 BACKGROUND

• 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.

  PMID: 28771923 BACKGROUND

• 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.

  PMID: 35379503 BACKGROUND

• 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.

  PMID: 22835900 BACKGROUND

• 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.

  PMID: 31630148 RESULT

• 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.

  PMID: 31196815 RESULT

• 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.

  PMID: 37227937 RESULT

MeSH Terms

Interventions

dapagliflozin

Study Officials

• Jin Chen, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Chen, MD

CONTACT

0086-28-87393195; jessicakxcj@uestc.edu.cn

Xinyi Tan, Master

CONTACT

0086-28-87398195

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice professor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 3, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)