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

NCT ID: NCT03218852

Last Updated: 2017-07-17

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

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-12-31

Brief Summary

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This study is an extended follow-up of the study (ClinicalTrials.gov ID: NCT01758120)-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

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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prednisone and cyclophosphamide

1. prednisone(0.5mg/kg/day\*6 months)
2. cyclophosphamide(1g intravenous use,per 1 month\*6months);
3. supportive care,including ACE-I or ARBs and blood pressure control

Group Type EXPERIMENTAL

prednisone and cyclophosphamide

Intervention Type DRUG

Prednisone and cyclophosphamide are both administered to participants in this group.

prednisone alone

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

Group Type EXPERIMENTAL

prednisone alone

Intervention Type DRUG

Prednisone is administered to participants in this group.

Interventions

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prednisone and cyclophosphamide

Prednisone and cyclophosphamide are both administered to participants in this group.

Intervention Type DRUG

prednisone alone

Prednisone is administered to participants in this group.

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

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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GGH2012-36-1

Identifier Type: -

Identifier Source: org_study_id

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