Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade

July 2, 2015 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Queen Mary Hospital
      • Hong Kong, China
        • Department of Medicine, the University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aliskiren
Drug: Aliskiren
Titrate from 150 mg daily to 300 mg daily
Other Names:
  • Rasilez

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of urine protein excretion rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in serum creatinine, eGFR, serum potassium and albumin
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Queen Mary Hospital, Hong Kong
United Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

June 14, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (ESTIMATE)

June 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 3, 2015

Last Update Submitted That Met QC Criteria

July 2, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Novartis-ST-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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