Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study
1 other identifier
interventional
25
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 3, 2015
July 1, 2015
1.4 years
June 14, 2009
July 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of urine protein excretion rate
6 months
Secondary Outcomes (1)
Changes in serum creatinine, eGFR, serum potassium and albumin
6 months
Study Arms (1)
Aliskiren
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Queen Mary Hospital, Hong Kongcollaborator
- United Christian Hospitalcollaborator
Study Sites (2)
Department of Medicine, The University of Hong Kong
Hong Kong, China
Queen Mary Hospital
Hong Kong, China
Related Publications (1)
Tang SC, Lin M, Tam S, Au WS, Ma MK, Yap DY, Ho YW, Lai KN. Aliskiren combined with losartan in immunoglobulin A nephropathy: an open-labeled pilot study. Nephrol Dial Transplant. 2012 Feb;27(2):613-8. doi: 10.1093/ndt/gfr349. Epub 2011 Jun 16.
PMID: 21680850DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sydney CW Tang, MD
The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 14, 2009
First Posted
June 17, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
July 3, 2015
Record last verified: 2015-07