Status:
COMPLETED
Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Queen Mary Hospital, Hong Kong
United Christian Hospital
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 nephro...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00922311
Start Date
July 1 2009
End Date
December 1 2010
Last Update
July 3 2015
Active Locations (2)
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1
Department of Medicine, The University of Hong Kong
Hong Kong, China
2
Queen Mary Hospital
Hong Kong, China