Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
- Registration Number
- NCT00922311
- Lead Sponsor
- The University of Hong Kong
- Brief 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.
- Detailed Description
This will be an open-label pilot study in which IgAN patients with persistent proteinuria despite maximum dose of ARB treatment will be assigned to receive Aliskiren. There is the optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of \<130/80 mmHg.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Aliskiren Aliskiren -
- Primary Outcome Measures
Name Time Method Change of urine protein excretion rate 6 months
- Secondary Outcome Measures
Name Time Method Changes in serum creatinine, eGFR, serum potassium and albumin 6 months
Trial Locations
- Locations (2)
Department of Medicine, The University of Hong Kong
🇨🇳Hong Kong, China
Queen Mary Hospital
🇨🇳Hong Kong, China