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

Primary Purpose

IgA Nephropathy

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Prednisone or Prednisolone
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IgA Nephropathy focused on measuring enough steroids, MCD, efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prednisone or Prednisolone

Arm Description

Outcomes

Primary Outcome Measures

24h urinary protein excretion

Secondary Outcome Measures

remission rate

Full Information

First Posted
October 7, 2011
Last Updated
July 9, 2012
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01451710
Brief Title
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
Official Title
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a single center,prospective,no-controlled clinical trial
Detailed Description
The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
Keywords
enough steroids, MCD, efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone or Prednisolone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Prednisone or Prednisolone
Other Intervention Name(s)
Prednisone, prednisolone, corticosteroids
Intervention Description
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
Primary Outcome Measure Information:
Title
24h urinary protein excretion
Time Frame
3 months
Secondary Outcome Measure Information:
Title
remission rate
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, MD
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23787555
Citation
Wang J, Juan C, Huang Q, Zeng C, Liu Z. Corticosteroid therapy in IgA nephropathy with minimal change-like lesions: a single-centre cohort study. Nephrol Dial Transplant. 2013 Sep;28(9):2339-45. doi: 10.1093/ndt/gft211. Epub 2013 Jun 19.
Results Reference
derived

Learn more about this trial

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

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