Mycophenolate Mofetil for IgA Nephropathy

NCT00863252 | Completed Phase 4

• 1 other identifier: Roche-ST-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

IGA Nephropathy

Keywords

proteinuria; creatinine; kidney survival; ESRD

Outcome Measures

Primary Outcomes (1)

• 24 hour urinary protein excretion

  18 months to 5 years

Secondary Outcomes (1)

• Renal survival Serum creatinine level and creatinine clearance Urine albumin-to-creatinine ratio

  at least 5 years

Study Arms (2)

1

EXPERIMENTAL

MMF

Drug: mycophenolate mofetil

2

ACTIVE COMPARATOR

Control

Drug: angiotensin blockade

Interventions

mycophenolate mofetil DRUG

Orally at 0.75 g bd to 1 g bd for 6 months

1

angiotensin blockade DRUG

Continuation of angiotensin blockade

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead
• United Christian Hospital: collaborator
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Department of Medicine and Geriatrics, United Christian Hospital

Hong Kong, China

Location

Related Publications (1)

• Tang S, Leung JC, Chan LY, Lui YH, Tang CS, Kan CH, Ho YW, Lai KN. Mycophenolate mofetil alleviates persistent proteinuria in IgA nephropathy. Kidney Int. 2005 Aug;68(2):802-12. doi: 10.1111/j.1523-1755.2005.00460.x.

  PMID: 16014059 RESULT

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria; Kidney Failure, Chronic

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Sydney CW Tang, MD, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2009
• First Posted: March 17, 2009
• Study Start: March 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: March 1, 2009
• Last Updated: March 17, 2009

Record last verified: 2009-03

Locations

CN (1)