End Stage Renal Disease on DialysisPhase 2EMPIRIC-PDNCT06483074
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
A Phase 2 study testing Empagliflozin 10 MG in people with End Stage Renal Disease on Dialysis and Peritoneal Dialysis Complication, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication, Sodium-glucose Cotransporter-2 Inhibitor
- What is being tested?
- Empagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Jul 2024to 31 Oct 2027
- Phase
- Phase 2
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
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong
Jack KC Ng, FRCP, 85237636098, jackng@cuhk.edu.hk
About this study
Official title: Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled Trial
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.
Read the detailed description
Diabetes is the leading cause of end stage kidney disease in developed countries. Peritoneal dialysis (PD) is a home-based and cost-effective modality of kidney placement therapy. Maintenance of residual kidney function (RKF) is one of the most crucial objectives to improve outcomes of PD patients. Observational studies showed that residual urine volume or residual glomerular filtration rate (GFR), but not peritoneal creatinine clearance, independently predicted patient survival. This benefit is likely attributed to better volume control, improved nutritional status, preserved endocrine function and enhanced clearance of uremic toxins in the presence of RKF. However, current therapeutic strategies to preserve RKF were most limited to the use of renin-angiotensin-aldosterone system (RAAS) inhibitors and biocompatible PD solutions.
Hong Kong adopted the 'PD-first' policy since 1985, and has the highest proportion of PD patients in the world. Inadequate dialysis, which is directly related to the loss of RKF, is the second most common reason for a permanent transfer to hemodialysis among PD patients. Sodium-glucose cotransporter-2 (SGLT-2) inhibitors have been shown to reduce albuminuria and delay progression of chronic kidney disease even in patients with advanced stages of kidney disease. It is postulated that the renoprotective effect of SGLT-2 inhibitors may be extended to dialysis population since a considerable proportion of patients still have urine output. SGLT2 inhibitors may potentially attenuate GFR decline in PD patients because heavy proteinuria independently predicted decline in residual GFR and onset of anuria. Moreover, preclinical studies suggested that empagliflozin reduced inflammation and oxidative stress by decreasing proinflammatory cytokines, inducing expression of anti-inflammatory M2 phenotype of macrophages, and antagonizing the effect of advanced glycation products. This beneficial effect may be particularly relevant to PD patients, where subclinical inflammation is common and inversely correlated with RKF.
Despite the potential promising effect of SGLT2-inhibitors in RKF in PD patients, dialysis patients were excluded in previous randomized controlled trials. In the present study, the investigators hypothesize that oral empagliflozin in addition to RAAS inhibitor, compared to RAAS inhibitor alone, better preserves RKF in patients newly started on PD. After a run-in period of 6 to 8 weeks where the dose of RAAS inhibitors are uptitrated to maximally tolerated dose, 48 incident PD patients will be randomized to empagliflozin or control (no empagliflozin) for a total of 6 months. This study aims to explore the feasibility of conducting a full-scale, adequately powered randomized controlled trial that investigates the effect of empagliflozin on RKF in incident PD patients.
- Conditions
- End Stage Renal Disease on Dialysis, Peritoneal Dialysis Complication, Sodium-glucose Cotransporter-2 Inhibitor, Residual Kidney Function
- Being tested
- Empagliflozin 10 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Jardiance 10mg daily
empagliflozin oral 10mg daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Empagliflozin 10 MG |
| Control group | No intervention | Patients randomized to control group will receive optimized dose of RAAS inhibitor for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients who are randomized each month following the run-in period
Measured: 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)
Measured: 6 months
Retention rate
Proportion of patients who have completed the whole study among patients that are randomized
Measured: 6 months
Secondary outcomes (12)
Slope of residual GFR
Residual GFR is calculated as the arithmetic mean of 24-hour urinary urea and creatinine clearances
Measured: 6 months
Time to anuria
Anuria is defined as urine volume <100ml per day
Measured: 6 months
Difference in residual urine volume
Residual urine volume is measured by 24-hour urine collection
Measured: Month 0, 2, 4, 6
Difference in volume of overhydration
Volume of overhydration is measured by a validated multi-frequency bioimpedance spectroscopy
Measured: Month 0, 2, 4, 6
Difference in plasma N-terminal pro-brain type natriuretic peptide
Indicator for left ventricular dysfunction
Measured: Month 0, 2, 4, 6
Difference in systolic blood pressure
Office blood pressure will be measured according to standardized protocol. The average of three consecutive measurements by an automated device will be recorded.
Measured: Month 0, 2, 4, 6
Difference in volume of ultrafiltration per day
The volume of fluid removed from patient by peritoneal dialysis each day
Measured: Month 0, 1, 2, 4, 6
Incidence of urinary tract infection
Proportion of patients who have symptoms consistent with urinary tract infection and organisms identified by urine culture
Measured: 6 months
Incidence of genital tract infection
Proportion of patients who are symptomatic and require antibiotic or anti-fungal treatment
Measured: 6 months
Incidence of ketoacidosis
Proportion of patients who have serum pH <7.3 and elevated serum beta hydroxybutyrate ≥3.0 mmol/L
Measured: 6 months
Incidence of lower limb amputation
Proportion of patients who require lower limb amputation by operation that is not secondary to trauma
Measured: 6 months
Incidence of severe hypoglycemia
Proportion of patients who have hypoglycemia requiring third party assistance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start29 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheuk-Chun SZETO, Chinese University of Hong Kong
- Investigators
- Jack KC Ng, FRCP, Principal investigator, Chinese University of Hong KongCheuk Chun Szeto, MD, FRCP, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483074
- Sponsor's protocol ID
- CREC 2024.090-T
- Acronym
- EMPIRIC-PD
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No