Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients
NCT ID: NCT06398977
Last Updated: 2024-05-03
Study Results
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Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-03-11
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Dagliflozin group
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.
Dapagliflozin
Dapagliflozin10MG, PO once daily
Control group
This group of patients received peritoneal dialysis and basic treatments such as antihypertensive and hypoglycemic therapy.
No interventions assigned to this group
Interventions
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Dapagliflozin
Dapagliflozin10MG, PO once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Sichuan Academy of Medical Sciences
OTHER
Responsible Party
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Jin Chen
vice professor
Principal Investigators
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Jin Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
Locations
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Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospita
Chengdu, Sichuan, China
Countries
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Central Contacts
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Xinyi Tan, Master
Role: CONTACT
Facility Contacts
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Xin Yi Tan, Master
Role: backup
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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DDLR-PD
Identifier Type: -
Identifier Source: org_study_id
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