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

Primary Purpose

IgA Nephropathy

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

irbesartan

methylprednisolone (MP) or prednisone (pred)

mycophenolate mofetil (MMF)

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring IgA nephropathy, mycophenolate mofetil

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The 1st Affiliated Hospital, Sun Yet-sen University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Pred group

MMF Group

Pred plus MMF Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Remission of proteinuria (complete or partial)

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)

Full Information

NCT ID

NCT00657059

First Posted

April 8, 2008

Last Updated

December 1, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT00657059

Brief Title

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

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

May 2019 (Actual)

Study Completion Date

May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IgA Nephropathy

Keywords

IgA nephropathy, mycophenolate mofetil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

151 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pred group

Arm Type

Active Comparator

Arm Description

Arm Title

MMF Group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Pred plus MMF Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

irbesartan

Other Intervention Name(s)

Aprovel, Sanofi-synthelabo

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

methylprednisolone (MP) or prednisone (pred)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

mycophenolate mofetil (MMF)

Other Intervention Name(s)

Cellcept,Roche

Intervention Description

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.

Primary Outcome Measure Information:

Title

Remission of proteinuria (complete or partial)

Time Frame

up to 4.3 years

Secondary Outcome Measure Information:

Title

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）

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials: