Residual Renal Function Preservation in Peritoneal Dialysis Patients

Not Applicable

• Conditions: Chronic Renal Disease
• Interventions: Drug: spirolactone; Other: blank control; Drug: Losartan

• Registration Number: NCT02190318
• Lead Sponsor: Second Xiangya Hospital of Central South University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-07
• Study First Submitted: 2014-07-12
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-15
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-01
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spirolactone	spirolactone	spirolactone is taken orally 20mg/d
losartan in combination with spirolactone	spirolactone	Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d
blank control	blank control	patients with antihypertensives besides ACEI/ARBs and spirolactone.
losartan in combination with spirolactone	Losartan	Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d
Losartan	Losartan	Losartan is taken orally 100mg/d

Primary Outcome Measures

Name	Time	Method
residual renal function of peritoneal dialysis patients	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 Measures

Name	Time	Method
peritoneal membrane function	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.