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.
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
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.
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- 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.
Xinyi Tan, Master contact
China1 site, 1 recruiting
- 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
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Sichuan Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Chen, Sichuan Academy of Medical Sciences
- Investigators
- Jin Chen, MD, Principal investigator, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
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 21317411Bargman 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 11562415Bello 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 36114414Parving 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 28106974Persson 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 34183431Zelniker 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 30786725Birkeland 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 28781064Persson 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 28771923Heidenreich 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 35379503Lui 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 22835900Li 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 31630148Mosenzon 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 31196815Barreto 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