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Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy (TOPplus-IgAN)

This study is currently recruiting participants.
Verified March 2013 by Guangdong General Hospital
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01758120
First received: December 12, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.


Condition Intervention Phase
IgA Nephropathy
 Drug: prednisone plus cyclophosphamide
Drug: Prednisone alone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy

Resource links provided by NLM:

MedlinePlus related topics: Steroids
U.S. FDA Resources

Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • the changes of kidney function [ Time Frame: 3,6 ,12, 24 and 36 months or more after treatment ] [ Designated as safety issue: Yes ]
    the changes of glomerular filtration rate (GFR) or a combination of reaching end-stage renal disease (ESRD) or doubling of serum Creatinine


Secondary Outcome Measures:
  • the changes of proteinuria [ Time Frame: 3,6 ,12, 24 and 36 months or more after treatment ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 1,3,6 ,12, 24 and 36 months or more after treatment ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events; adverse events include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis.


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prednisone plus cyclophosphamide
prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months)
 Drug: prednisone plus cyclophosphamide
prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months)
Experimental: prednisone alone
prednisone alone: prednisone(0.5mg/kg/day*6 months)
 Drug: Prednisone alone
prednisone alone: prednisone(0.5mg/kg/day*6 months)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758120

Contacts
Contact: Wei Shi, MD, PhD (86-20)83850849 weishi_gz@126.com

Locations
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Bin Zhang, MD PhD     +86-13925056339     zhangbinyes@yahoo.com.cn    
Contact: Zhongling Feng, Master     +86-13828431229     13828431229@139.com    
Sub-Investigator: 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            
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: wei shi, MD PhD Guangdong General Hospital
  More Information

No publications provided

Responsible Party: Wei Shi, Prof., Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01758120     History of Changes
Other Study ID Numbers: GGH2012-36, GGH2012-36
Study First Received: December 12, 2012
Last Updated: March 18, 2013
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
IgA nephropathy
Cyclophosphamide
prednisone

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013