Clinical trial NCT00657059: Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)
Official title: A Prospective, Multicenter, Randomized Controlled Trial of Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: IgA Nephropathy
Keywords: IgA nephropathy
mycophenolate mofetil
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 151
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Remission of proteinuria (complete or partial)
timeFrame: up to 4.3 years
Secondary outcomes:
measure: 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)
timeFrame: every 6 month for 4.3 years（including 3 months ARB leading-in phase， 1 years' treatment phase and 3 years' follow-up）
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University,Guangxi
name: Yunha Liao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of nephrology, People's Hospital of Yunnan Province
name: Jinli Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology,1st People's Hospital of Guangzhou
name: Junzhou Fu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 2nd Affiliated Hospital of Sun Yet-Sen University,Guangzhou
name: Anping Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 1st Affiliated hospital of Zhengzhou University, Henan
name: Zhangsuo liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 3nd affiliated hospital of Sun yatsent university, Guangzhou
name: Tanqi lou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, 2nd Affiliated Hospital of Anhui Medical University, Anhui
name: Li Hao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, General Hospital of Ningxia Medical University, Ningxia
name: Menghua Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Nephrology, The First Affiliated Hospital of Nanchang University, Jiangxi
name: Qinkai Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: