Effect of Different Dialysis Dosage on Prognosis in Maintenance Peritoneal Dialysis Patients

NCT00912821 | Completed Phase 4 DMC

• 1 other identifier: 08dz1900501-b
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

End-stage Renal Disease

Keywords

Renal Replacement Therapy; Peritoneal dialysis

Outcome Measures

Primary Outcomes (1)

• clinical outcome including mortality and technical failure

  2 years

Secondary Outcomes (1)

• complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality

  2 years

Study Arms (2)

8 L dialysate

ACTIVE COMPARATOR

8 L peritoneal dialysis solution

Drug: 8 L dialysate

6 L dialysate

EXPERIMENTAL

6 L peritoneal dialysis solution

Drug: 6 L dialysate

Interventions

6 L dialysate DRUG

6 L peritoneal dialysis solution

6 L dialysate

8 L dialysate DRUG

8 L peritoneal dialysis solution

8 L dialysate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 80, male or female.
• End stage renal disease patients (eGFR \< 15 ml/min/1.73 m2).
• Maintenance peritoneal dialysis within 6 months after initiation of PD.
• With informed consent.

You may not qualify if:

• Acute renal injury.
• Patients with an expected follow up less than 6 months sch as renal transplantation.
• Transferred from hemodialysis or renal transplantation.
• Residual renal function eGFR less than 1 ml/min.
• HIV positive.
• Cancer patients.
• Unstable organ disease such as active tuberculosis and severe hepatitis. Patients with an expected follow up less than 48 weeks, such as planned kidney transplant.
• Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University school of medicine

Shanghai, 200001, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Dialysis Solutions

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director, Department of Nephrology, Renji Hospital

Study Record Dates

• First Submitted: June 1, 2009
• First Posted: June 3, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2012
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

CN (1)