Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

IgA Nephropathy Clinical Trial

Official title:

Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00922311
• Other study ID #: Novartis-ST-01
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2009
• Last updated: July 2, 2015
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2015
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Aliskiren
Titrate from 150 mg daily to 300 mg daily

Locations

Country	Name	City	State
China	Department of Medicine, The University of Hong Kong	Hong Kong
China	Queen Mary Hospital	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
The University of Hong Kong	Queen Mary Hospital, Hong Kong, United Christian Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of urine protein excretion rate		6 months	Yes
Secondary	Changes in serum creatinine, eGFR, serum potassium and albumin		6 months	Yes