A single-blind, double dummy, randomized, multi-dose, two sequence, crossover, study to investigate the effects of Renin Inhibitor (aliskiren 300 mg) on Albuminuria in nondiabetic nephropathy patients treated with ramipril 10 mg and Volume intervention (CSPP100A2260, ARIA study)

Phase 2

Completed

• Conditions: nondiabetic nephropathy; 10029149

• Registration Number: NL-OMON36542
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

• Male and female patients, 18 years of age and above
• Non-diabetic renal disease with residual albuminuria of >300 mg/24 hrs from 24 hour urine collection during conventional RAAS-blockade of at least 8 weeks of ACE inhibition or ARB treatment at the maximum recommended dose.
• GFR >30 ml/min/1.73m2 as determined by creatinine clearance
• Patients with a history of hypertension and msSBP of <160 mm Hg and msDBP <105 mm Hg at screening and baseline.
• Female subjects of child bearing potential must be using two acceptable methods of contraception.
• BMI within the range of 18 to 35 kg/m2.

Exclusion Criteria

• Aliskiren use in the past 3 months.
• Renovascular hypertension or severe hypertension (msDBP >=110 mmHg and msSBP >=180 mmHg).
• Pregnancy, lactation.
• A medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last 6 months.
• Diabetes mellitus (Type 1 and 2).
• Heart failure NYHA class III-IV.
• High rate of renal function loss (decline in creatinine clearance >6 ml/min/1.73m2 during the previous year or 1.5 ml/min/1.73m2 per month).
• Albuminuria >3 g/24h and/ or hypoalbuminaemia <28 g/L.
• Serum potassium >5.3 mmol/L.
• Within the last 3 years and/or recurrent history of acute or chronic bronchospastic disease.
• Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications (see protocol for details).
• HIV, hepatitis B or C positive.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proteinuria.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>RAAS biomarkers, GFR, blood pressure, side effects.</p><br>