Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483074
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-23
Brief Title:
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients a Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPIRIC-PD
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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None