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

Phase 4

• Conditions: IgA Nephropathy
• Interventions: Drug: prednisone and cyclophosphamide; Drug: prednisone alone

• Registration Number: NCT03218852
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-07
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-12
• Last Update Submitted: 2017-07-12
• Study First Posted: 2017-07-17
• Last Update Posted: 2017-07-17
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 133

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the changes of kidney function or death	a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)	1. addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment; 2. the changes of estimated glomerular filtration rate (eGFR) or a combination of reaching end-stage renal disease (ESRD) or doubling of serum Creatinine or death

Secondary Outcome Measures

Name	Time	Method
the changes of proteinuria	a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)	1. addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment; 2. the changes of proteinuria
Number of Participants with Adverse Events	a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)	1. addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment; 2. Number of Participants with Adverse Events; adverse events include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis.

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China