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

July 12, 2017 updated by: Wei Shi, Guangdong Provincial People's Hospital

A Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3,6 ,12, 24 and 36 months or more after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
the changes of proteinuria
Time Frame: 3,6 ,12, 24 and 36 months or more after treatment
3,6 ,12, 24 and 36 months or more after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1,3,6 ,12, 24 and 36 months or more after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: wei shi, MD PhD, Guangdong Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 25, 2012

First Posted (Estimate)

January 1, 2013

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGH2012-36 (Other Identifier: GGH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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