Progressive Immunoglobulin A (IgA) nephrology Urological and Genital Diseases Progressive Immunoglobulin A (IgA) nephrology
Conditions
Interventions
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 - t
Sponsors
Cinkate Pharmaceutical Corporate (China)
Eligibility
Sex/Gender
All
Inclusion criteria
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 (Lee?s classification grade II to IV) 3. Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Loss of renal function (defined as serum creatinine increased by 200% or a reduce of 50% in the estimated GFR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Discontinuation of therapy due to adverse effect | — |
Countries
China
Outcome results
None listed