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

IgA Nephropathy Clinical Trial

— e-TOPplus  

Official title:

An Extended Follow-up of the Prospective Randomized, Controlled, Open-labeled Trial of Prednisone Plus Cyclophosphamide in Patients With Advanced Stage IgA Nephropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03218852
• Other study ID #: GGH2012-36-1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 7, 2016
• Last updated: July 12, 2017
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: July 2017
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• prednisone and cyclophosphamide
Prednisone and cyclophosphamide are both administered to participants in this group.
• prednisone alone
Prednisone is administered to participants in this group.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the changes of kidney function or death	addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment; 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	the changes of proteinuria	addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment; the changes of proteinuria	a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)
Secondary	Number of Participants with Adverse Events	addition of 2-year-follow up to the ClinicalTrials.gov ID: NCT01758120;Time Frame:4 years and 5 years after the initiation of treatment; Number of Participants with Adverse Events; adverse events include hair loss, vomiting, diarrhea, jaundice, leukopenia, anemia, thrombocytopenia, infections, allergic reactions and hemorrhagic cystitis.	a total of 5 years of followup (addition of 2-year-follow up to the ClinicalTrial of NCT01758120)