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Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

This study has been completed.
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
United Christian Hospital
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00922311
First received: June 14, 2009
Last updated: August 3, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
IgA Nephropathy
 Drug: Aliskiren
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study

Resource links provided by NLM:

Drug Information available for: Aliskiren
U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change of urine protein excretion rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in serum creatinine, eGFR, serum potassium and albumin [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren Drug: Aliskiren
Titrate from 150 mg daily to 300 mg daily
Other Name: Rasilez

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922311

Locations
China, Hksar
Department of Medicine, The University of Hong Kong
Hong Kong, Hksar, China
China
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
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sydney CW Tang, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00922311     History of Changes
Other Study ID Numbers: Novartis-ST-01
Study First Received: June 14, 2009
Last Updated: August 3, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by The University of Hong Kong:
Proteinuria

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
 Urologic Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013