The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients

NCT01854814 | Completed

• 1 other identifier: MAIN
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 3

Brief Summary

The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (2)

• To evaluate the effects of mycophenolate mofetil on a composite renal outcomes in subjects with advanced IgA nephropathy

  Time to the first occurrence of a component of the composite renal endpoint: Doubling of serum creatinine or the onset of end stage renal disease (ESRD) \[needing chronic dialysis or renal transplantation or renal death\]

  3 years

• To evaluate the effects of mycophenolate mofetil on progression of CKD in subjects with advanced IgA nephropathy

  A decrease in eGFR of 30% or more and to a level of less than 60 ml/min at the exit visit if the baseline eGFR was 60 ml/min or more. Or a decrease in eGFR of 50% or more at the exit visit if the baseline eGFR was less than 60 ml/min.

  3 years

Secondary Outcomes (2)

• To evaluate the effects of mycophenolate mofetil on the changes of proteinuria in subjects with advanced IgA nephropathy

  3 years

• To evaluate the effects of mycophenolate mofetil rapid progression of CKD in subjects with advanced IgA nephropathy

  3 years

Study Arms (2)

mycophenolate mofetil

EXPERIMENTAL

mycophenolate mofetil 1.5g/day and maximum tolerated labeled dose of losartan

Drug: Mycophenolate mofetil

losartan

ACTIVE COMPARATOR

maximus tolerated labeled dose of losartan

Drug: Losartan

Interventions

Mycophenolate mofetil DRUG

Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan

mycophenolate mofetil

Losartan DRUG

Maximum tolerated labeled dose of Losartan

losartan

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven primary IgA nephropathy with urinary proteinuria excretion over 1g/24 hour,subjects must meet 2 of the following criteria:
• global glomerular sclerosis plus focal segmental glomerular sclerosis ratio ≥50%
• eGFR 30 to 60 ml/min
• Hypertension (blood pressure over 140/90 mmHg or taking antihypertensive drugs)

You may not qualify if:

• Secondary IgA nephropathy
• Familial IgA nephropathy
• Concomitant disease: cancer, infection, diabetes mellitus, connective tissue disease, abnormal liver function
• Pregnancy or breasting
• Inability to comply with study and follow-up procedures

Sponsors & Collaborators

• Fan Fan Hou: lead

Study Sites (3)

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The Fourth People's Hospital Shenzhen

Shenzhen, Guangdong, 518000, China

Location

The Institute of Nephrology, Guangdong Medical College

Zhanjiang, Guangdong, 524001, China

Location

Related Publications (4)

• Tang SC, Tang AW, Wong SS, Leung JC, Ho YW, Lai KN. Long-term study of mycophenolate mofetil treatment in IgA nephropathy. Kidney Int. 2010 Mar;77(6):543-9. doi: 10.1038/ki.2009.499. Epub 2009 Dec 23.

  PMID: 20032964 BACKGROUND

• Frisch G, Lin J, Rosenstock J, Markowitz G, D'Agati V, Radhakrishnan J, Preddie D, Crew J, Valeri A, Appel G. Mycophenolate mofetil (MMF) vs placebo in patients with moderately advanced IgA nephropathy: a double-blind randomized controlled trial. Nephrol Dial Transplant. 2005 Oct;20(10):2139-45. doi: 10.1093/ndt/gfh974. Epub 2005 Jul 19.

  PMID: 16030050 BACKGROUND

• 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

• Hou FF, Xie D, Wang J, Xu X, Yang X, Ai J, Nie S, Liang M, Wang G, Jia N; MAIN Trial Investigators. Effectiveness of Mycophenolate Mofetil Among Patients With Progressive IgA Nephropathy: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2254054. doi: 10.1001/jamanetworkopen.2022.54054.

  PMID: 36745456 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Mycophenolic Acid; Losartan

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

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Fan Fan Hou, M.D., PhD

  Division of nephrology, Nanfang Hospital Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Division of Nephrology

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 16, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

CN (3)