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

NCT03218852 | Unknown Phase 4

• 1 other identifier: GGH2012-36-1
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• the changes of kidney function or death

  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

  a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)

Secondary Outcomes (2)

• the changes of proteinuria

  a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)

• Number of Participants with Adverse Events

  a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)

Study Arms (2)

prednisone and cyclophosphamide

EXPERIMENTAL

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

Drug: prednisone and cyclophosphamide

prednisone alone

EXPERIMENTAL

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

Drug: prednisone alone

Interventions

prednisone and cyclophosphamide DRUG

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

prednisone and cyclophosphamide

prednisone alone DRUG

Prednisone is administered to participants in this group.

prednisone alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• biopsy-proven primary IgA nephropathy
• years old
• elevated serum Creatinine and less than 3.0mg/dl
• with a written consent from participants to receive prednisone and/or cyclophosphamide

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Prednisone; Cyclophosphamide

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: July 17, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)