Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Main hypothesis: compared with prednisone separately, leflunomide combined with prednisone can reduce proteinuria, delay the progression of Chronic Kidney Disease (CKD) and preserve renal function in progressive IgAN.
Secondary hypothesis: leflunomide combined with prednisone in treatment of IgAN is safe for at least 12 months.
Ethics approval
Renji Hospital Research Ethics Committee approval given on 25/05/2004 (reference number: [2004]12A).
Study design
Multicentre randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Progressive Immunoglobulin A (IgA) nephrology
Intervention
Please note that as of 02/07/2007, the anticipated end date of this trial has been extended to 31/12/2007. The anticipated end date of this trial was again extended on 08/04/2008 to 31st June 2008 - this is due to problems with recruitment.
After enrolment, patients are randomised to prednisone or prednisone together with leflunomide for one year and then followed up for two years.
Intervention type
Drug
Phase
Not Specified
Drug names
Leflunomide, prednisone
Primary outcome measures
Loss of renal function (defined as serum creatinine increased by 200% or a reduce of 50% in the estimated GFR)
Secondary outcome measures
Discontinuation of therapy due to adverse effect
Overall trial start date
01/06/2004
Overall trial end date
30/06/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age 18-65 years
2. Renal biopsy diagnosed primary IgAN in three months before enrolment and proteinuria more than one gram per 24 hours, in conjunction with a decreased renal function at diagnosis (estimated Glomerular Filtration Rate [GFR] less than 60 ml/min and more than 29 ml/min, evaluated by the Modification in Diet of Renal Disease [MDRD] equation) and/or histological unfavorable criteria (Lees classification grade II to IV)
3. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Rapidly progressive IgAN (IgAN with rapid decline in renal function and/or histological characterized by necrotizing capillaritis and crescent formation)
2. Secondary IgAN (e.g. clinical and history evidence of Henoch-Schönlein purpura, hepatitis related nephropathy, other renal and systemic diseases such as Systemic Lupus Erythematosus (SLE), Goodpasture syndrome, vasculitis and diabetics nephropathy)
3. The intake of immunosuppressive drugs more than one week during the last six months
4. The intake of prednisone or prednisolone more than 20 mg per day over four weeks during the last six months
5. Serum creatinine more than 250 umol/l at enrolment
6. Current signs of severe disease such as severe infection
7. Hepatitis B serology positive, except when only Hepatitis B Surface Antibody (HBsAb) positive
8. Elevation of hepatic aminotransferase
9. Previous malignancy, known Human Immunodeficiency Virus (HIV) test positive, psychiatric antecedent, active central nervous disease, severe gastrointestinal disease and other situations forbidden with immunosuppression agents
10. Abnormal in glucose metabolism, fasting glucose over 6.2 mmol/l
11. Pregnancy, breast feeding or inadequate contraception if female
12. Allergy to a study medication or reluctant to participate in the study
Recruitment start date
01/06/2004
Recruitment end date
30/06/2008
Locations
Countries of recruitment
China
Trial participating centre
Renji Hospital
Shanghai
200001
China
Sponsor information
Organisation
Cinkate Pharmaceutical Corporate (China)
Sponsor details
129 Da Tian Road
11- A & B Jia Fa Mansion
Shanghai
200041
China
Sponsor type
Industry
Website
Funders
Funder type
University/education
Funder name
Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary