Aliskiren Combined With Losartan in Proteinuric, Non-diabetic Chronic Kidney Disease

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Study objective: To investigate the potential anti-proteinuric and renoprotective efficacy of aliskiren in addition to losartan in patients at risk of developing end-stage renal disease (ESRD)

Methods: This will be a randomized, double-blind study in which proteinuric, non-diabetic patients with chronic kidney disease (CKD) will be assigned in a 1:1 ratio to one of the following treatment groups for 3 years:

• Group A: Losartan (Control arm: conventional treatment)*

• Group B: Aliskiren plus Losartan (Intervention arm)*

• With optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of <130/80 mmHg.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Angiotensin Receptor Antagonists; Losartan

Criteria

Inclusion Criteria:

• Male or female 18 - 80 years of age

• Presence of nondiabetic CKD stages 3 to 4 as defined by estimated glomerular filtration rate (eGFR by 4-variable MDRD equation) as follows:

• Stage 3: Moderate decrease in GFR 30-59 mL/min/1.73 sq.m

• Stage 4: Severe decrease in GFR 15-29 mL/min/1.73 sq.m

• CKD is defined as either kidney damage or GFR <60 mL/min/1.73 m2 for > 3 months with variations of less than 30% in the 3 months before screening

• Early-morning urinary protein-to-creatinine ratio of >500 mg/g or 57 mg/mmol on at least 2 occasions four weeks apart

• Patients who are willing to give written, informed consent

Exclusion Criteria:

• eGFR < 15 or > 60 ml/min/1.73m2

• Early-morning urinary protein-to-creatinine ratio of >5000 mg/g or 570 mg/mmol, or urinary protein-to-creatinine ratio of <500 mg/g or 57 mg/mmol

• Serum K+ > 5.2 mmol/L

• Presence of bilateral renal artery stenosis

• Known allergy to losartan or aliskiren

• Patients who are receiving angiotensin II receptor blocker / angiotensin converting enzyme inhibitor combination within 12 weeks of randomization

• Concurrent treatment with corticosteroids, nonsteroidal antiinflammatory drugs, or immunosuppressive agent

• Patients with connective tissue disease or obstructive uropathy

• Patients with concomitant malignancy or any such conditions that will severely limit life expectancy

• Female who are pregnant or intending to conceive

• Female of child-bearing age who are unwilling to practice effective contraception

• Patients who are unable to give informed consent

• Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study