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

NCT ID: NCT01451710

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-05-31

Brief Summary

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This is a single center,prospective,no-controlled clinical trial

Detailed Description

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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

Conditions

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IgA Nephropathy

Keywords

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enough steroids MCD efficacy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prednisone or Prednisolone

Group Type EXPERIMENTAL

Prednisone or Prednisolone

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Prednisone, prednisolone, corticosteroids

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhi-Hong Liu, M.D.

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhihong Liu, MD

Role: STUDY_DIRECTOR

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

Locations

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

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 23787555 (View on PubMed)

Other Identifiers

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NJCT-1102

Identifier Type: -

Identifier Source: org_study_id