Residual Renal Function Preservation in Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients

Conditions
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Chronic Renal Disease

Intervention / Treatment
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* Drug: Losartan
* Drug: spirolactone
* Other: blank control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Losartan<br>Losartan is taken orally 100mg/d | Drug: Losartan<br> <br> |
| Experimental: spirolactone<br>spirolactone is taken orally 20mg/d | Drug: spirolactone<br> <br> |
| Experimental: losartan in combination with spirolactone<br>Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d | Drug: Losartan<br> <br> Drug: spirolactone<br> <br> |
| Sham Comparator: blank control<br>patients with antihypertensives besides ACEI/ARBs and spirolactone. | Other: blank control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peritoneal membrane function | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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residual renal function；, RAAS, peritoneal dialysis；