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

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

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.

Study Overview

• Status: Unknown
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: prednisone and cyclophosphamide; Drug: prednisone alone

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prednisone and cyclophosphamide; prednisone(0.5mg/kg/day*6 months); cyclophosphamide(1g intravenous use,per 1 month*6months);; supportive care,including ACE-I or ARBs and blood pressure control	Drug: prednisone and cyclophosphamide; Prednisone and cyclophosphamide are both administered to participants in this group.
Experimental: prednisone alone; prednisone(0.5mg/kg/day*6months);; supportive care,including ACE-I or ARBs and blood pressure control	Drug: prednisone alone; Prednisone is administered to participants in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 12, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, IGA; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Prednisone
• Other Study ID Numbers: GGH2012-36-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No