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Extended Follow-up of Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy (e-TOPplus)

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.
 
ClinicalTrials.gov Identifier: NCT03218852
Recruitment Status : Active, not recruiting
First Posted : July 17, 2017
Last Update Posted : July 17, 2017
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong Provincial People's Hospital

Brief Summary:
This study is an extended follow-up of the study (ClinicalTrials.gov ID: NCT01758120)-Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Drug: prednisone and cyclophosphamide Drug: prednisone alone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy
Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: prednisone and cyclophosphamide
  1. prednisone(0.5mg/kg/day*6 months)
  2. cyclophosphamide(1g intravenous use,per 1 month*6months);
  3. supportive care,including ACE-I or ARBs and blood pressure control
Drug: prednisone and cyclophosphamide
Prednisone and cyclophosphamide are both administered to participants in this group.

Experimental: prednisone alone
  1. prednisone(0.5mg/kg/day*6months);
  2. supportive care,including ACE-I or ARBs and blood pressure control
Drug: prednisone alone
Prednisone is administered to participants in this group.




Primary Outcome Measures :
  1. the changes of kidney function or death [ Time Frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120) ]
    1. addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment
    2. 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 :
  1. the changes of proteinuria [ Time Frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120) ]
    1. addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment
    2. the changes of proteinuria

  2. Number of Participants with Adverse Events [ Time Frame: a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120) ]
    1. addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment
    2. Number of Participants with Adverse Events; adverse events include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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)

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): NCT03218852


Locations
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China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Guangdong Provincial People's Hospital
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Responsible Party: Wei Shi, Clinical Professor, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03218852    
Other Study ID Numbers: GGH2012-36-1
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: July 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases
Prednisone
Cyclophosphamide
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