Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.

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

Details

• Lead Sponsor: The University of Hong Kong
• Collaborators: Queen Mary Hospital, Hong Kong; United Christian Hospital

Criteria

Inclusion Criteria:

• Male or female 18 - 70 years of age

• Histologic diagnosis of IgA nephropathy

• Proteinuria > 1 g/day or UPC > 1 mg/mg or 113 mg/mmol at least twice

• Receiving treatment with the maximum dose of ARB for at least 3 months

• Patients who are willing to give written, informed consent

Exclusion Criteria:

• eGFR < 15 ml/min/1.73 sq.m

• UPC >5000 mg/g or 570 mg/mmol, or <500 mg/g or 57 mg/mmol

• Serum K+ > 5.2 mmol/L

• Presence of bilateral renal artery stenosis

• Presence of diabetes mellitus

• Renal histology showing pathologies other than IgAN

• Known allergy to ARB or DRI

• Patients on ARB/ACEi combination within 12 weeks of randomization

• Concurrent treatment with corticosteroids, Nsaid, or immunosuppressant

• Patients with connective tissue disease or obstructive uropathy

• Patients with malignancy or conditions severely limiting life expectancy

• Female who are pregnant or intending to conceive

• Female of child-bearing age unwilling to practice contraception

• Patients who are unable to give informed consent

• Patients simultaneously participating in another study