Residual Renal Function Preservation in Peritoneal Dialysis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02190318
• Date of registration: 12/07/2014
• Prospective Registration: No
• Primary sponsor: Second Xiangya Hospital of Central South University
• Public title: Residual Renal Function Preservation in Peritoneal Dialysis Patients
• Scientific title: The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients
• Date of first enrolment: November 2013
• Target sample size: 96
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02190318
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Hong Liu, MD,phD

• Name: Hong Liu, MD,phD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients who having been on PD continuously for one month, urine volume>600 ml/d,
residual renal function>2ml/min/1.73m2, blood pressure>120/70mmHg, serum potassium
levels<5.5mmol/l, stable clinical condition.

Exclusion Criteria:

- Patients with infectious systemic disease, peritonitis during the preceding 1 month,
who had taken ACEI/ARBs in the 3 preceding months, spirolactone in the 2 preceding
weeks, intolerance to ACEI/ARBs, CHF, MI, malignant hypertension and stroke within
the preceding 6 months.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Renal Disease

Intervention(s)

Drug: spirolactone

Other: blank control

Drug: Losartan

Primary Outcome(s)

residual renal function of peritoneal dialysis patients [Time Frame: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.]

Secondary Outcome(s)

peritoneal membrane function [Time Frame: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.]

Secondary ID(s)

CHN-RENAL-IIS-2013-029

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Baxter Healthcare Corporation