Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06642597
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
STarting incrEmental Prescription of Peritoneal Dialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An International Multi-centre Randomised Controlled Trial Co-designed With Consumers With Lived Experience of Peritoneal Dialysis PD to Determine the Optimal Approach to Starting Patients With Kidney Failure on PD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEP-PD
Brief Summary:
Kidney failure is fatal without dialysis Peritoneal dialysis PD completed at home offers greater flexibility and autonomy for patients However PD is often prescribed for 24 hoursday 7 daysweek for every patient starting dialysis This practice is not evidence-informed may be unnecessary and potentially harmful The STEP-PD trial aims to determine the optimal approach to commencing patients on PD through starting at low dose PD and incrementing over time
Detailed Description:
The STEP-PD study is an investigator-initiated pragmatic international multicentre prospective adaptive randomised open-label parallel group non-inferiority trial led by an international multi-disciplinary team of clinician scientists nephrologists consumers social scientists trialists health economists dialysis nurses statisticians and registry experts The STEP-PD trial is co-designed with consumers with lived experience of peritoneal dialysis PD to determine the optimal approach to starting patients with kidney failure on PD Specifically this trial will test the hypothesis that compared with full dose PD starting patients on incremental start PD preserves symptom burden related quality of life QOL reduces dialysis burden is safe is more environmentally sustainable and costs less for patients the community and the healthcare system The STEP-PD trial has the potential to transform and personalise the treatment of kidney failure globally by providing definitive evidence on the patient-prioritised question regarding the effectiveness and safety of incremental start PD particularly in relation to the patient-critical outcome of symptom burden-related QOL Favourable results would lead to a paradigm shift in how patients are started on PD thereby mitigating unnecessarily burdensome expensive and possibly harmful treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None