Condition category
Urological and Genital Diseases
Date applied
28/06/2006
Date assigned
28/07/2006
Last edited
08/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jiaqi Qian

ORCID ID

Contact details

Renji Hospital
Renal Division
145 Shandong Middle Road
Shanghai
200001
China

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 (Lee’s 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

http://www.cinkate.com.cn

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

Publication citations

Additional files

Editorial Notes