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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01758120
First received: December 12, 2012
Last updated: December 7, 2016
Last verified: December 2016
  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:


Further study details as provided by Guangdong General Hospital:

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


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.


Enrollment: 133
Study Start Date: December 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (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
  1. prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months);
  2. supportive care,including ACE-I or ARBs and blood pressure control
Experimental: prednisone alone
prednisone alone: prednisone(0.5mg/kg/day*6 months)
Drug: Prednisone alone
  1. prednisone alone: prednisone(0.5mg/kg/day*6 months);
  2. supportive care,including ACE-I or ARBs and blood pressure control

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • biopsy-proven primary IgA nephropathy;
  • 18-70 years old;
  • elevated serum Creatinine and less than 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758120

Locations
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: wei shi, MD PhD Guangdong General Hospital
  More Information

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: December 7, 2016
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
IgA nephropathy
Cyclophosphamide
prednisone

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

ClinicalTrials.gov processed this record on December 09, 2016