Mycophenolate Mofetil for IgA Nephropathy

This study has been completed.
Sponsor:
Collaborators:
United Christian Hospital
Queen Mary Hospital, Hong Kong
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00863252
First received: March 15, 2009
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

IgA nephropathy (IgAN) is the commonest primary glomerulonephritis worldwide. In Hong Kong, IgAN accounts for approximately 30% of all primary glomerular diseases, and a significant proportion of young patients (< 50 years of age) on dialysis therapy are sufferers of primary IgAN. To date, no specific therapeutic agent has been consistently shown to halt the progression of IgAN to end-stage renal failure, particularly in patients with persistent significant proteinuria and the presence of chronic tubulointerstitial inflammation on kidney biopsy. In recent years, angiotensin-converting enzyme inhibitors (ACEI) have been found capable of significantly reducing proteinuria in some IgAN patients, while others, particularly those with the ACE DD genotype, showed either absent or unsatisfactory response to angiotensin blockade. Mycophenolate mofetil (MMF) is a marketed immunosuppressive drug which acts by releasing mycophenolic acid (MPA) to inhibit the de novo pathway of purine synthesis, and hence is relatively selective for lymphocytes. Apart from being efficacious for the prophylaxis of renal allograft rejection and for the induction of remission in severe lupus nephritis, MMF has been anecdotally reported to avert progression to allograft failure in recurrent IgAN of the transplanted kidney. Data on the clinical efficacy of MMF in the treatment of primary IgAN, however, is lacking. In the current proposal, we aim to study the clinical efficacy of MMF in patients with biopsy-proven IgAN and clinically significant proteinuria despite angiotensin blockade. Patients will be followed up for at least 5 years to track any survival difference between groups.


Condition Intervention Phase
IGA Nephropathy
Drug: mycophenolate mofetil
Drug: angiotensin blockade
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open Label, Case-Controlled Study on the Efficacy of Mycophenolate Mofetil for IgA Nephropathy Patients With Heavy Proteinuria Despite Angiotensin Blockade

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 24 hour urinary protein excretion [ Time Frame: 18 months to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal survival Serum creatinine level and creatinine clearance Urine albumin-to-creatinine ratio [ Time Frame: at least 5 years ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2002
Study Completion Date: March 2009
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MMF
Drug: mycophenolate mofetil
Orally at 0.75 g bd to 1 g bd for 6 months
Active Comparator: 2
Control
Drug: angiotensin blockade
Continuation of angiotensin blockade

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females between the ages of 18 and 70 years
  • Renal biopsy showing a histological diagnosis IgAN, with predominant or codominant mesangial deposition of IgA on immunofluorescent studies
  • Daily urinary protein excretion > 1 g on at least 3 separate occasions
  • Serum creatinine < 400 umol/L
  • Patients who are willing to give written informed consent and to participate in and comply with the study protocol

Exclusion Criteria:

  • Presence of concomitant glomerular diseases
  • Patients with known hypersensitivity to MMF
  • Patients receiving treatment with other cytotoxic agents
  • Serum creatinine > 400 umol/L
  • Women who are lactating, pregnant or of childbearing potential not using, or who are unwilling to use, a reliable contraceptive method during and for 6 weeks following conclusion of MMF therapy. A pregnancy test to exclude pregnancy will be performed for women of childbearing potential prior to recruitment
  • Patients who are unable or unwilling to give written informed consent and to participate in and comply with the study protocol
  • Presence of systemic infection or malignancy requiring therapy at the time of entry to the study
  • Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00863252

Locations
China
Department of Medicine and Geriatrics, United Christian Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
United Christian Hospital
Queen Mary Hospital, Hong Kong
Investigators
Principal Investigator: Sydney CW Tang, MD, PhD The University of Hong Kong
  More Information

Publications:
Responsible Party: Dr Sydney C.W. Tang, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00863252     History of Changes
Other Study ID Numbers: Roche-ST-01
Study First Received: March 15, 2009
Last Updated: March 16, 2009
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
proteinuria
creatinine
kidney survival
ESRD

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014