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

End-stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00912821
• Other study ID #: 08dz1900501-b
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2009
• Last updated: October 12, 2016
• Start date: March 2009
• Est. completion date: July 2012

Study information

• Verified date: October 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

To investigate the effect, feasibility and safety of 6L of dialysate per day after initiation of peritoneal dialysis (PD), we 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: 6L of dialysate per day and 8L of dialysate per day, follow up will be regularly performed at baseline, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks, 60 weeks, 72 weeks, 84 weeks and 96 weeks. Serum biochemical parameters, Kt/V, residual renal function (RRF), life quality and cardiovascular test will be regularly recorded. Clinical outcomes such as mortality, technique failure, complications and life quality between the two groups will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age from 18 to 80, male or female.

2. End stage renal disease patients (eGFR < 15 ml/min/1.73 m2).

3. Maintenance peritoneal dialysis within 6 months after initiation of PD.

4. With informed consent.

Exclusion Criteria:

1. Acute renal injury.

2. Patients with an expected follow up less than 6 months sch as renal transplantation.

3. Transferred from hemodialysis or renal transplantation.

4. Residual renal function eGFR less than 1 ml/min.

5. HIV positive.

6. Cancer patients.

7. 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.

8. Other conditions regarded as unsuitability by investigator, such as pregnancy, severe malnutrition and recent peritonitis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• 6 L dialysate
6 L peritoneal dialysis solution
• 8 L dialysate
8 L peritoneal dialysis solution

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiao Tong University school of medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcome including mortality and technical failure		2 years	Yes
Secondary	complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality		2 years	Yes