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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

Page last updated: August 23, 2015

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