Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients

April 30, 2024 updated by: Jin Chen, Sichuan Academy of Medical Sciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xinyi Tan, Master
  • Phone Number: 0086-28-87398195

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospita
        • Contact:
        • Contact:
          • Xin Yi Tan, Master
          • Phone Number: 0086-28-87393195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Dapagliflozin
Dapagliflozin10MG, PO once daily
Other Names:
  • dagliflozin
No Intervention: Control group
This group of patients received peritoneal dialysis and basic treatments such as antihypertensive and hypoglycemic therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2,12 and 24 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in renal Kt/Vurea
Time Frame: Baseline, 2, 12 and 24 weeks.
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).
Baseline, 2, 12 and 24 weeks.
Change in BNP（Brain natriuretic peptide）
Time Frame: Baseline, 2, 12 and 24 weeks.
Concentration of serum BNP which could assess cardiac function.
Baseline, 2, 12 and 24 weeks.
Change in EF%
Time Frame: Baseline and 24 weeks.
The ejection fraction (EF%) value was measured using echocardiography by the hospital's ultrasound department, with all ultrasound examinations conducted by two attending physicians.
Baseline and 24 weeks.
Change in ultrafiltration
Time Frame: Baseline, 2, 12 and 24 weeks.
The total amount of water removed from the body through dialysis each day.
Baseline, 2, 12 and 24 weeks.
Change in HbA1C （Hemoglobin A1C) rate
Time Frame: Baseline, 12 and 24 weeks.
Rate of Glycated Hemoglobin (HbA1C) as an Indicator of Long-term Glycemic Control in Serum.
Baseline, 12 and 24 weeks.
Change in serum sodium concentration
Time Frame: Baseline, 2, 12 and 24 weeks.
Concentration of sodium ions in the blood.
Baseline, 2, 12 and 24 weeks.
Change in urinary sodium concentration
Time Frame: Baseline, 2, 12 and 24 weeks.
The concentration of sodium in the 24-hour urine.
Baseline, 2, 12 and 24 weeks.
Change in dialysate sodium concentration
Time Frame: Baseline, 2, 12 and 24 weeks.
The concentration of sodium in the 24-hour dialysate.
Baseline, 2, 12 and 24 weeks.
Change in urinary glucose concentration
Time Frame: Baseline, 2, 12 and 24 weeks.
The concentration of glucose in the 24-hour urine.
Baseline, 2, 12 and 24 weeks.
Change in blood pressure
Time Frame: Baseline, 2, 12 and 24 weeks.
The bloody pressure of the patient in the morning.
Baseline, 2, 12 and 24 weeks.
Change in body weight
Time Frame: Baseline, 2, 12 and 24 weeks.
The weight of the patient is measured on an empty stomach without containing dialysate.
Baseline, 2, 12 and 24 weeks.
Episodes of peritonitis
Time Frame: 24 weeks.
The number of episodes of a patient during the trial.
24 weeks.
Hospitalization
Time Frame: 24 weeks.
The number of patients admitted to hospital during the trial.
24 weeks.
Time of dropout PD
Time Frame: 24 weeks.
The point in time at which a patient either discontinues PD treatment or experiences death during the trail.
24 weeks.
Concentration in Dapagliflozin 3-O-Glucuronide in urine
Time Frame: Baseline, 2, 12 and 24 weeks.
Concentration of Dapagliflozin 3-O-Glucuronide in urine indicating Dapagliflozin metabolic activity.
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 dialysate reflecting Dapagliflozin metabolism.
Baseline, 2, 12 and 24 weeks.
concentration of Dapagliflozin 3-O-Glucuronide in serum
Time Frame: Baseline, 2, 12 and 24 weeks.
Concentration of Dapagliflozin 3-O-Glucuronide in serum reflecting Dapagliflozin metabolism.
Baseline, 2, 12 and 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Academy of Medical Sciences

Investigators

  • Principal Investigator: Jin Chen, MD, Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 3, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDLR-PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peritoneal Dialysis Complication

Clinical Trials on Dapagliflozin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe