Leflunomide treatment in progressive Immunoglobulin A Nephropathy (IgAN), a multi-centre, prospective, randomised controlled study
| ISRCTN | ISRCTN97636235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97636235 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/06/2006
- Registration date
- 28/07/2006
- Last edited
- 08/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jiaqi Qian
Scientific
Scientific
Renji Hospital
Renal Division
145 Shandong Middle Road
Shanghai
200001
China
Study information
| Study design | Multicentre randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Renji Hospital Research Ethics Committee approval given on 25/05/2004 (reference number: [2004]12A). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Leflunomide, prednisone |
| Primary outcome measure | 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 study start date | 01/06/2004 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2004 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- China
Study participating centre
Renji Hospital
Shanghai
200001
China
200001
China
Sponsor information
Cinkate Pharmaceutical Corporate (China)
Industry
Industry
129 Da Tian Road
11- A & B Jia Fa Mansion
Shanghai
200041
China
| Website | http://www.cinkate.com.cn |
|---|
Funders
Funder type
University/education
Renal Division, Renji Hospital, Shanghai Jiaotong University School of Medicine
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
