The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

July 9, 2012 updated by: Zhi-Hong Liu, M.D., Nanjing University School of Medicine
This is a single center,prospective,no-controlled clinical trial

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
  2. The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Female or male patients aged between 18 to 65 years
  • Renal biopsy was used to diagnose IgA nephropathy
  • Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L

Exclusion Criteria:

  • Patients with serum creatinine ≥ 3 mg/dl or eGFR < 30ml/min per 1.73 m2
  • urine RBC > 1 million/ml
  • Patients who have received treatment of enough steroids for more than 12 weeks
  • patients with secondary IgA
  • Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis
  • Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prednisone or Prednisolone
Drug: Prednisone or Prednisolone
daily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day
Other Names:
  • Prednisone, prednisolone, corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
24h urinary protein excretion
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
remission rate
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Nanjing University School of Medicine

Investigators

  • Study Director: Zhihong Liu, MD, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

October 7, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (Estimate)

October 14, 2011

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-1102

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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