Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

NCT00318474 | Terminated Phase 3 Results DMC

• 3 other identifiers: 04PE116IND #48,977Canadian Control #076948
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements (FOS).

Conditions

IgA Nephropathy

Keywords

Proteinuria; Immunoglobulin A

Outcome Measures

Primary Outcomes (1)

• Change in Proteinuria - Uprotein/Creatinine Ratio

  Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.

  Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.

Secondary Outcomes (1)

• Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level

  12 months

Study Arms (2)

Mycophenolate Mofetil (MMF)

ACTIVE COMPARATOR

Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.

Drug: Mycophenolate Mofetil (MMF); Drug: ACEi; Drug: FOS

MMF Placebo

PLACEBO COMPARATOR

Subjects receive MMF placebo.

Drug: MMF Placebo; Drug: ACEi; Drug: FOS

Interventions

Mycophenolate Mofetil (MMF) DRUG

Oral administration of MMF; dose based on body size (between 25mg/kg/day and 36ng/kg/day); maximum dose 1gm BID.

Also known as: CellCept

Mycophenolate Mofetil (MMF)

MMF Placebo DRUG

Placebo only, oral administration

MMF Placebo

ACEi DRUG

Administer same as pre-treatment regimen.

Also known as: angiotensin converting enzyme inhibitors

MMF Placebo; Mycophenolate Mofetil (MMF)

FOS DRUG

Administer same as pre-treatment regimen

Also known as: fish oil supplement

MMF Placebo; Mycophenolate Mofetil (MMF)

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ages 7-70 years old
• Renal biopsy, diagnostic for IgA nephropathy
• Must be able to take oral medication

You may not qualify if:

• Clinical and histologic evidence of systemic lupus erythematosus
• Well-documented history of Henoch-Schonlein purpura.
• Clinical evidence of cirrhosis or chronic liver disease
• Abnormal laboratory values at the time of study entry
• Estimated GFR outside of protocol defined limits
• History of significant gastrointestinal disorder
• Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C.
• Other major organ system disease or malignancy
• Current or prior treatment with MMF or azathioprine

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Related Publications (2)

• Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.

  PMID: 38864363 DERIVED

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Proteinuria

Interventions

Mycophenolic Acid; Angiotensin-Converting Enzyme Inhibitors

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

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Ron Hogg, M.D.
• Organization: Saint Joseph's Hospital and Medical Center

ronhogg@gmail.com

602-406-3246

Study Officials

• Ronald J Hogg, M.D.

  St. Joseph's Hospital and Medical Center, Phoenix

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 26, 2006
• Study Start: January 1, 2002
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2010
• Last Updated: March 7, 2016
• Results First Posted: October 1, 2014

Record last verified: 2016-02

Locations

US (1)