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

This study is currently recruiting participants.
Verified March 2014 by Sun Yat-sen University
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00657059
First received: April 8, 2008
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
IgA Nephropathy
Drug: irbesartan
Drug: methylprednisolone (MP) or prednisone (pred)
Drug: mycophenolate mofetil (MMF)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Remission of proteinuria (complete or partial) [ Time Frame: up to 4.3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: September 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Pred Group: Prednisone treatment
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 Name: 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: 2
MMF Group: MMF treatment
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 Name: 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 Name: Cellcept,Roche
Active Comparator: 3
Pred plus MMF Group: Prednisone plus MMF treatment
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 Name: 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 Name: Cellcept,Roche

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.

  Eligibility

Ages Eligible for Study:   14 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657059

Contacts
Contact: Xueqing Yu, MD 8620-87766335 yuxq@mail.sysu.edu.cn
Contact: Qiongqiong Yang, MD 8620-87755766 ext 8843 qqyzzm@yahoo.com.cn

Locations
China, Guangdong
The 1st Affiliated Hospital, Sun Yet-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xueqing Yu, MD    8620-87766335    yuxq@mail.sysu.edu.cn   
Contact: Qiongqiong Yang    8620-87755766 ext 8843    qqyzzm@yahoo.com.cn   
Principal Investigator: Xueqing Yu, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Xueqing Yu/Director, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00657059     History of Changes
Other Study ID Numbers: SYSU-PRGIgAN-001
Study First Received: April 8, 2008
Last Updated: March 19, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
IgA nephropathy
mycophenolate mofetil

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Irbesartan
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids

ClinicalTrials.gov processed this record on April 23, 2014