NCT03970018: PDP-ADPKD

ADPKD and Peritoneal Dialysis: How Anticipate Peritoneal Pressure?

Completed Last updated 31 May 2019

What this trial tests

trial testing Intra-peritoneal pressure in Autosomal Dominant Polycystic Kidney Disease in 210 participants. Completed in 1 September 2018.

Timeline

1 December 2017

Primary endpoint
1 July 2018

1 September 2018

Quick facts

Lead sponsor	CHU de Reims
Status	Completed
Study type	OBSERVATIONAL
Enrollment	210
Start date	1 December 2017
Primary completion	1 July 2018
Estimated completion	1 September 2018
Sites	1 location across France

Drugs / interventions tested

• Intra-peritoneal pressure

Conditions studied

• Autosomal Dominant Polycystic Kidney Disease — all drugs for Autosomal Dominant Polycystic Kidney Disease →

Sponsor

CHU de Reims — full company profile →

Who can join

18 and older, any sex, with Autosomal Dominant Polycystic Kidney Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Autosomal dominant polycystic kidney disease (ADPKD) is first genetic kidney disease and fourth etiology of end stage renal disease in the world. Peritoneal dialysis is underuse in this population. Indeed in this pathology, behind big kidneys and big liver, a hyper pressure is feared with technical failure. The lack of abdominal space could generate increase of peritoneal pressure. Hyper pressure is already known to be a risk factor of technical failure and over mortality in peritoneal dialysis patients (all nephropathies included). It depends on body mass index and body surface modulating injected volume for each patient. Anticipate peritoneal pressure in this population ADPKD could be an important information for distinguish those who can use peritoneal dialysis without fear and those at risk of technical failure.

The primary objective is to create and validate prediction score for intra-peritoneal pressure, in peritoneal dialysis for ADPKD patients thanks to clinical and radiological values.

The secondary objectives are to study the association between intra-peritoneal pressure and patient's outcome (global survival and technical survival).

Retrospective, multicentric, national, cohort study will be performed. For the first step (score creation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2010 and 31/12/2015 with tomodensitometry between one year before beginning and one year after were included.

For the second step (score validation): ADPKD patients starting peritoneal dialysis for end stage renal failure between 01/01/2016 and 31/12/2017 with tomodensitometry between one year before beginning and one year after were included.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.