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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:
ClinicalTrials.gov Identifier:
NCT01758120
First Posted: January 1, 2013
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Wei Shi, 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 ]
    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 ]

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


Enrollment: 135
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, clinical professor, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01758120     History of Changes
Other Study ID Numbers: GGH2012-36
GGH2012-36 ( Other Identifier: GGH )
First Submitted: December 12, 2012
First Posted: January 1, 2013
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Wei Shi, 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