eflunomide treatment in progressive Immunoglobulin A Nephropathy (IgAN), a multi-centre, prospective, randomised controlled study

Completed

• Conditions: Progressive Immunoglobulin A (IgA) nephrology; Urological and Genital Diseases

• Registration Number: ISRCTN97636235
• Lead Sponsor: Cinkate Pharmaceutical Corporate (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified