Residual Renal Function Preservation in Peritoneal Dialysis Patients

Central South University

Status: Unknown

Conditions: Chronic Renal Disease

Treatments: Drug: spirolactone; Drug: Losartan; Other: blank control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02190318

CHN-RENAL-IIS-2013-029

Details and patient eligibility

About

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 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 4 patient groups

Losartan

Experimental group

Description:

Losartan is taken orally 100mg/d

Treatment:

Drug: Losartan

spirolactone

Experimental group

Description:

spirolactone is taken orally 20mg/d

Treatment:

Drug: spirolactone

losartan in combination with spirolactone

Experimental group

Description:

Losartan is taken orally 100mg/d and spirolactone is taken orally 20mg/d

Treatment:

Drug: spirolactone

Drug: Losartan

blank control

Sham Comparator group

Description:

patients with antihypertensives besides ACEI/ARBs and spirolactone.

Treatment:

Other: blank control