Treatment of Prednisone Plus Cyclophosphamide in Patients With Advanced-stage IgA Nephropathy

NCT ID: NCT01758120

Last Updated: 2017-07-14

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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prednisone plus cyclophosphamide

prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day\*6 months) plus cyclophosphamide(1g intravenous use,per 1 month\*6months)

Group Type EXPERIMENTAL

prednisone plus cyclophosphamide

Intervention Type DRUG

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

prednisone alone

prednisone alone: prednisone(0.5mg/kg/day\*6 months)

Group Type EXPERIMENTAL

Prednisone alone

Intervention Type DRUG

1. prednisone alone: prednisone(0.5mg/kg/day\*6 months);
2. supportive care,including ACE-I or ARBs and blood pressure control

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wei Shi

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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wei shi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GGH2012-36

Identifier Type: -

Identifier Source: org_study_id

GGH2012-36

Identifier Type: OTHER

Identifier Source: secondary_id

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