Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

December 1, 2019 updated by: Xue Qing Yu, Sun Yat-sen University

A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

A multi-center, randomized, controlled clinical trial to evaluate the short-term and long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and preserving renal function in patients with IgAN who have pre-treated (and continue to be treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are four phases of study for each subject. Phase 1 the screening phase. During this phase each potential subject will be evaluated to determine if he/she is eligible for the study.

Phase 2 the ARB lead-in phase will last for three months. Phase 3 the intervention phase. Each subject will be randomly received 12 months treatment with the study drugs (MMF, prednisone or MMF plus prednisone) Phase 4 following-up phase. All the patients will be followed by 3 years after study drug stopped.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The 1st Affiliated Hospital, Sun Yet-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willingness to sign an informed consent
  • Age:14~60 years, regardless of gender
  • Clinical evaluation and renal biopsy diagnostic for IgAN, excluded secondary IgAN. Renal histological criteria should be defined by Lee's glomerular grading system.
  • 1 g/day <= proteinuria < 3.5 g/day, or UPr/Cr ratio ≥ 0.6 (male) or ≥ 0.8 (female) when taking ARB
  • eGFR ≥ 40 mL/min/1.73 m2

Exclusion Criteria:

  • Inability or unwillingness to sign the informed consent
  • Inability or unwillingness to meet the scheme demands raised by the investigators
  • Rapidly progressive nephritic syndrome and acute renal failure, including rapidly progressive IgAN ( IgAN with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents.
  • Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis
  • est GFR < 40 mL/min/1.73m2
  • Malignant hypertension that is difficult to be controlled by oral drugs
  • Cirrhosis, chronic active liver disease.
  • History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease.)
  • Any 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 (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)
  • Malignant tumors (except fully cured basal cell carcinoma)
  • Absolute neutrophil count < 1500／mm3, absolute platelet count <75000／mm3 or hematocrit (Hct) <28% (anemic subjects may be reevaluated after the anemia has been treated.)
  • Known allergy, contraindication or intolerance to the MMF, corticosteroids or ACEI/ARB.
  • Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception
  • Current exposure to MMF or azathioprine. In case of current treatment with oral steroid or ACEI/ARB, entry is permitted after corticosteroids or ACEI/ARB are stopped for 2 weeks.
  • Current or recent (within 30 days) exposure to any other investigational drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pred group
Pred Group: Prednisone treatment Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month.
Drug: irbesartan
In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( < 5 g NaCl/day), and then given a stable dose (150mg ~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase.
Other Names:
  • Aprovel, Sanofi-synthelabo
Drug: methylprednisolone (MP) or prednisone (pred)
Patients will take oral Pred ( 0.5 mg/kg/d) on alternate days, and on the first, third and fifth months of the drug treatment phase, patients will be given intravenous pulse therapy with methylprednisolone ( 0.5 g/day) for 3 successive days. And after 6 months, Pred should be tapered to be stopped until the end of the 12-month course of treatment.
Active Comparator: MMF Group
MMF Group: MMF treatment Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then 0.5 bid for the remaining 6-month.
Drug: irbesartan
In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( < 5 g NaCl/day), and then given a stable dose (150mg ~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase.
Other Names:
  • Aprovel, Sanofi-synthelabo
Drug: mycophenolate mofetil (MMF)
Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then to 0.5 bid (wt ≥ 50kg) for the remaining 6-month.
Other Names:
  • Cellcept,Roche
Active Comparator: Pred plus MMF Group

Pred plus MMF Group: Prednisone plus MMF treatment. Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month.

Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then 0.5 bid for the remaining 6-month.
Drug: irbesartan
In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( < 5 g NaCl/day), and then given a stable dose (150mg ~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase.
Other Names:
  • Aprovel, Sanofi-synthelabo
Drug: methylprednisolone (MP) or prednisone (pred)
Patients will take oral Pred ( 0.5 mg/kg/d) on alternate days, and on the first, third and fifth months of the drug treatment phase, patients will be given intravenous pulse therapy with methylprednisolone ( 0.5 g/day) for 3 successive days. And after 6 months, Pred should be tapered to be stopped until the end of the 12-month course of treatment.
Drug: mycophenolate mofetil (MMF)
Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then to 0.5 bid (wt ≥ 50kg) for the remaining 6-month.
Other Names:
  • Cellcept,Roche

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Remission of proteinuria (complete or partial)
Time Frame: up to 4.3 years
up to 4.3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation)
Time Frame: every 6 month for 4.3 years（including 3 months ARB leading-in phase， 1 years' treatment phase and 3 years' follow-up）
every 6 month for 4.3 years（including 3 months ARB leading-in phase， 1 years' treatment phase and 3 years' follow-up）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Xueqing Yu, MD, Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
  • Principal Investigator: Yunha Liao, MD, Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University,Guangxi
  • Principal Investigator: Jinli Zhang, MD, Department of nephrology, People's Hospital of Yunnan Province
  • Principal Investigator: Junzhou Fu, MD, Department of Nephrology,1st People's Hospital of Guangzhou
  • Principal Investigator: Anping Xu, MD, Department of Nephrology, 2nd Affiliated Hospital of Sun Yet-Sen University,Guangzhou
  • Principal Investigator: Zhangsuo liu, MD, Department of Nephrology, 1st Affiliated hospital of Zhengzhou University, Henan
  • Principal Investigator: Tanqi lou, MD, Department of Nephrology, 3nd affiliated hospital of Sun yatsent university, Guangzhou
  • Principal Investigator: Li Hao, MD, Department of Nephrology, 2nd Affiliated Hospital of Anhui Medical University, Anhui
  • Principal Investigator: Menghua Chen, MD, Department of Nephrology, General Hospital of Ningxia Medical University, Ningxia
  • Principal Investigator: Qinkai Chen, MD, Department of Nephrology, The First Affiliated Hospital of Nanchang University, Jiangxi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 8, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

December 1, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-PRGIgAN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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