Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT00922311
• Collaborator: Queen Mary Hospital, Hong Kong (Other), United Christian Hospital (Other)
• Enrollment: 25
• Locations: 2
• Arm: 1
• Duration (Months): 17
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
IgA Nephropathy	Drug: Aliskiren	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aliskiren	Drug: Aliskiren; Titrate from 150 mg daily to 300 mg daily; Other Names: Rasilez

Outcome Measures

Primary Outcome Measures

1. Change of urine protein excretion rate [6 months]

Secondary Outcome Measures

1. Changes in serum creatinine, eGFR, serum potassium and albumin [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine, The University of Hong Kong	Hong Kong		China
2	Queen Mary Hospital	Hong Kong		China

Sponsors and Collaborators

• The University of Hong Kong
• Queen Mary Hospital, Hong Kong
• United Christian Hospital

Investigators

• Principal Investigator: Sydney CW Tang, MD, The University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00922311
• Other Study ID Numbers: Novartis-ST-01
• First Posted: Jun 17, 2009
• Last Update Posted: Jul 3, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by , ,: Proteinuria
• Additional relevant MeSH terms: Kidney Diseases; Glomerulonephritis, IGA

Study Results

No Results Posted as of Jul 3, 2015