Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Academy of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dapagliflozin

    Drug

    Dapagliflozin10MG, PO once daily

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Dagliflozin groupActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline, 2,12 and 24 weeks.

Secondary outcomes

1

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).

Time frame
Baseline, 2, 12 and 24 weeks.
2

Change in BNP(Brain natriuretic peptide)

Concentration of serum BNP which could assess cardiac function.

Time frame
Baseline, 2, 12 and 24 weeks.
3

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.

Time frame
Baseline and 24 weeks.
4

Change in ultrafiltration

The total amount of water removed from the body through dialysis each day.

Time frame
Baseline, 2, 12 and 24 weeks.

Other outcomes

Sponsors and contacts

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