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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03218852

Acronym

e-TOPplus

Enrollment

133

Registered

2017-07-17

Start date

2016-12-31

Completion date

2021-12-31

Last updated

2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

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.

Interventions

DRUGprednisone and cyclophosphamide

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

DRUGprednisone alone

Prednisone is administered to participants in this group.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026