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NCT00912821

Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients - A Prospective, Randomized, Controlled, Multi-center Clinical Study

Completed Phase 4 Last updated 12 October 2016
What this trial tests

Phase 4 trial testing 6 L dialysate in End-stage Renal Disease in 200 participants. Completed in 1 July 2012.

Timeline
1 March 2009
Primary endpoint
1 June 2011
1 July 2012

Quick facts

Lead sponsorShanghai Jiao Tong University School of Medicine
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment200
Start date1 March 2009
Primary completion1 June 2011
Estimated completion1 July 2012
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Jiao Tong University School of Medicine

Who can join

Adults 18 to 80, any sex, with End-stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Peritoneal dialysis (PD) is an important model of renal replacement therapy for end-stage renal disease (ESRD) patients. Thus far, evidence for the initiation dosage of PD treatment is lacking, most patients begin their PD with four 2 L exchanges per day. However, many patients have their residual renal function at the initiation of PD, an 8 L dialysate per day will enhance the toxicity of bioincompatible dialysate and increase the economic burden compared with that of 6 L dialysate per day. Thus, the investigators perform a prospective, randomized, controlled, multi-center clinical study. The patients initiation of PD treatment within 6 months are randomized to be assigned to two groups: 6 L of dialysate per day and 8 L of dialysate per day, follow up will be regularly performed until 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.

Publications & conference data

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

Verify or expand the search:

Other recruiting trials for End-stage Renal Disease

Currently open trials in the same condition.

Other Shanghai Jiao Tong University School of Medicine trials

Trials by the same sponsor.

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Data sources for this page

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