Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
Primary Purpose
IgA Nephropathy
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aliskiren
Sponsored by
About this trial
This is an interventional treatment trial for IgA Nephropathy focused on measuring Proteinuria
Eligibility 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
Sites / Locations
- Department of Medicine, The University of Hong Kong
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aliskiren
Arm Description
Outcomes
Primary Outcome Measures
Change of urine protein excretion rate
Secondary Outcome Measures
Changes in serum creatinine, eGFR, serum potassium and albumin
Full Information
NCT ID
NCT00922311
First Posted
June 14, 2009
Last Updated
July 2, 2015
Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, United Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00922311
Brief Title
Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
Official Title
Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
Collaborators
Queen Mary Hospital, Hong Kong, United Christian Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
Proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aliskiren
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
Rasilez
Intervention Description
Titrate from 150 mg daily to 300 mg daily
Primary Outcome Measure Information:
Title
Change of urine protein excretion rate
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in serum creatinine, eGFR, serum potassium and albumin
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sydney CW Tang, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, The University of Hong Kong
City
Hong Kong
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
21680850
Citation
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.
Results Reference
derived
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Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
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