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

A 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

NCT01758120

Acronym

TOPplus-IgAN

Enrollment

135

Registered

2013-01-01

Start date

2012-12-31

Completion date

2019-12-31

Last updated

2017-07-14

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

Conditions

IgA Nephropathy

Keywords

IgA nephropathy, Cyclophosphamide, prednisone

Brief summary

Treatment of prednisone plus cyclophosphamide may be superior to treatment of prednisone alone in patients with advanced-stage IgA nephropathy.

Interventions

DRUGprednisone plus cyclophosphamide

1. prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day\*6 months) plus cyclophosphamide(1g intravenous use,per 1 month\*6months); 2. supportive care,including ACE-I or ARBs and blood pressure control

DRUGPrednisone alone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

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	3,6 ,12, 24 and 36 months or more after 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

Secondary

Measure	Time frame
the changes of proteinuria	3,6 ,12, 24 and 36 months or more after treatment

Other

Measure	Time frame	Description
Number of Participants with Adverse Events	1,3,6 ,12, 24 and 36 months or more after treatment	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