Residual Renal Function Preservation in Peritoneal Dialysis Patients

Overview

Aldosterone blockade is useful in preserving residual renal function in patients on PD.The long term efficacy of dual blockade of the RAAS is better than monotherapy.

Full Title of Study: “The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

Detailed Description

Residual renal function has been proven to contribute to improved survival and quality of life of dialysis patients. It is now recognized as an important factor in the prognosis of PD.The RAAS system is involved in the development of renal diseases. Angiotensin II and aldosterone are vital in this process. The beneficial effect of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker on residual renal function has been demonstrated in peritoneal dialysis patients. Unfortunately, neither ACE inhibition nor angiotensin receptor blocker fully supprsses aldosterone production. Now much focus has been placed on aldosterone antagonist.

Interventions

  • Drug: Losartan
  • Drug: spirolactone
  • Other: blank control

Arms, Groups and Cohorts

  • Experimental: Losartan
    • Losartan is taken orally 100mg/d
  • Experimental: spirolactone
    • spirolactone is taken orally 20mg/d
  • Experimental: losartan in combination with spirolactone
    • Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d
  • Sham Comparator: blank control
    • patients with antihypertensives besides ACEI/ARBs and spirolactone.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
    • peritoneal membrane function is measured by peritoneal equilibration test to test the type of peritoneal transport. Briefly, a standard 4-hour dwell period was used (first exchange of the day), using a 2.5% glucose concentration 2-L volume exchange. The patient used their usual overnight dialysis regimen, and both the overnight and test drainage volumes were measured.The dialysate:plasma ratio of creatinine at the completion of the 4-hour dwell period (D/Pcreat) was used as the estimate of low-molecular-weight solute transport.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Second Xiangya Hospital of Central South University
  • Collaborator
    • Baxter Healthcare Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hong Liu, deputy director of nephrology department – Second Xiangya Hospital of Central South University
  • Overall Contact(s)
    • Hong Liu, MD,phD, 86-0731-85292057, liuh0618@163.com

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