Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients

NCT06483074 | Recruiting Phase 2

• 1 other identifier: CREC 2024.090-T
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Empagliflozin, a new class of diabetes medication, has demonstrated a reduction in renal function decline among patients with chronic kidney disease, regardless of their diabetes status. However, all previous studies excluded dialysis patients. Patients starting dialysis may still produce a certain amount of urine. Importantly, patients with better preserved residual kidney function tend to have better control of blood pressure and volume status, improved nutrition status, higher quality of life and reduced mortality rate. The purpose of this study is to learn about the safety of empagliflozin in patients on peritoneal dialysis, in preparation for a future large clinical trial. Participants who newly initiate peritoneal dialysis will be randomly allocated to either empagliflozin on top of standard of care, or standard of care alone. Over a follow-up period of six months, the investigators will collect information on urine volume, blood pressure and glucose control. Safety, tolerability and drug compliance of empagliflozin will also be evaluated. If empagliflozin is found to be safe and well tolerated in patients on peritoneal dialysis, further large-scale randomized controlled trial may be conducted to evaluate its impact on residual kidney function and other relevant clinical outcomes.

Conditions

End Stage Renal Disease on Dialysis; Peritoneal Dialysis Complication; Sodium-glucose Cotransporter-2 Inhibitor; Residual Kidney Function

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Number of patients who are randomized each month following the run-in period

  During randomization

• Medication adherence

  Proportion of prescribed empagliflozin that are taken by the patients (pill counting will be done by investigators at each follow up)

  6 months

• Retention rate

  Proportion of patients who have completed the whole study among patients that are randomized

  6 months

Secondary Outcomes (12)

• Slope of residual GFR

  6 months

• Time to anuria

  6 months

• Difference in residual urine volume

  Month 0, 2, 4, 6

• Difference in volume of overhydration

  Month 0, 2, 4, 6

• Difference in plasma N-terminal pro-brain type natriuretic peptide

  Month 0, 2, 4, 6

Other Outcomes (3)

• Change in peritoneal solute transfer rate

  Month 0, 6

• Difference in frailty status by Clinical Frailty Scale

  Month 0, 6

• Difference in frailty status by Fried frailty phenotype

  Month 0, 6

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Patients randomized to intervention group will receive oral empagliflozin 10mg daily on top of optimized dose of RAAS inhibitor for 6 months

Drug: Empagliflozin 10 MG

Control group

NO INTERVENTION

Patients randomized to control group will receive optimized dose of RAAS inhibitor for 6 months

Interventions

Empagliflozin 10 MG DRUG

empagliflozin oral 10mg daily for 6 months

Also known as: Jardiance 10mg daily

Intervention 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:

• Incident PD patients within 90 days of Tenckhoff catheter insertion
• Age 18-75 years old
• Patient with or without history of Type 2 diabetes
• Residual GFR (defined as the average of 24-hour urinary urea and creatinine clearances) \> 2ml/min/1.73m2 AND urine volume \> 400ml per day
• Patients who are willing to provide written informed consent

You may not qualify if:

• Patients with history of hemodialysis (≥ 3 months) or renal transplant
• Life expectancy \<6 months
• Prior use of any type of SGLT2 inhibitors within 1 month before screening visit
• Poorly controlled diabetes with HBA1c \>11%
• Type 1 diabetes
• History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)
• Peritonitis within 4 weeks
• Ketoacidosis within 5 years
• Known hypersensitivity to empagliflozin or other SGLT2 inhibitors
• Any active acute or chronic physical or mental conditions that, in the opinion of the investigator, might interfere with the compliance of participants to or the performance of this study
• Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

empagliflozin

Study Officials

• Jack KC Ng, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Cheuk Chun Szeto, MD, FRCP

  Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Jack KC Ng, FRCP

CONTACT

+852 37636098; jackng@cuhk.edu.hk

Phyllis Cheng, BN

CONTACT

+852 35053528; pcheng809@yahoo.com.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: July 1, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)