Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
Information source: Guangdong General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: IgA Nephropathy
Intervention: prednisone plus cyclophosphamide (Drug); Prednisone alone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Guangdong General Hospital Official(s) and/or principal investigator(s): wei shi, MD PhD, Principal Investigator, Affiliation: Guangdong General Hospital
Overall contact: Wei Shi, MD, PhD, Phone: (86-20)83850849, Email: weishi_gz@126.com
Summary
Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone
alone in patients with advanced-stage IgA nephropathy.
Clinical Details
Official title: A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: the changes of kidney function
Secondary outcome: the changes of proteinuria
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- biopsy-proven primary IgA nephropathy;
- 18-70 years old;
- serum Creatinine: 1. 5-3. 0mg/dl;
- with a written consent from participants to receive prednisone and/or
cyclophosphamide
Exclusion Criteria:
- diabetes;
- contraindications for the treatment of prednisone and/or cyclophosphamide;
- any treatment with steroids or immunosuppressive drugs prior to this study;
- acute deterioration of renal function(including those of glomerular origin)
Locations and Contacts
Wei Shi, MD, PhD, Phone: (86-20)83850849, Email: weishi_gz@126.com
Guangdong General Hospital, Guangzhou, Guangdong 510080, China; Recruiting Bin Zhang, MD PhD, Phone: +86-13925056339, Email: zhangbinyes@yahoo.com.cn Zhongling Feng, Master, Phone: +86-13828431229, Email: 13828431229@139.com Bin Zhang, MD PhD, Sub-Investigator zhongling Feng, Master, Sub-Investigator Jianteng Xie, Master, Sub-Investigator Huaban Liang, Master, Sub-Investigator Lixia Xu, MD PhD, Sub-Investigator
Additional Information
Starting date: December 2012
Last updated: August 17, 2015
|