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Mycophenolate Mofetil for IgA Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00863252
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : March 17, 2009
United Christian Hospital
Queen Mary Hospital, Hong Kong
Information provided by:
The University of Hong Kong

Brief Summary:
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 or disease Intervention/treatment Phase
IGA Nephropathy Drug: mycophenolate mofetil Drug: angiotensin blockade Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2002
Actual Primary Completion Date : June 2004
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: 1
Drug: mycophenolate mofetil
Orally at 0.75 g bd to 1 g bd for 6 months

Active Comparator: 2
Drug: angiotensin blockade
Continuation of angiotensin blockade

Primary Outcome Measures :
  1. 24 hour urinary protein excretion [ Time Frame: 18 months to 5 years ]

Secondary Outcome Measures :
  1. Renal survival Serum creatinine level and creatinine clearance Urine albumin-to-creatinine ratio [ Time Frame: at least 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00863252

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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
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Principal Investigator: Sydney CW Tang, MD, PhD The University of Hong Kong
Publications of Results:
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Responsible Party: Dr Sydney C.W. Tang, The University of Hong Kong Identifier: NCT00863252    
Other Study ID Numbers: Roche-ST-01
First Posted: March 17, 2009    Key Record Dates
Last Update Posted: March 17, 2009
Last Verified: March 2009
Keywords provided by The University of Hong Kong:
kidney survival
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action