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

NCT01758120 | Unknown Phase 4 DMC

• 1 other identifier: GGH2012-36
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgA Nephropathy

Keywords

IgA nephropathy; Cyclophosphamide; prednisone

Outcome Measures

Primary Outcomes (1)

• the changes of kidney function or death

  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

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

Secondary Outcomes (1)

• the changes of proteinuria

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

Other Outcomes (1)

• Number of Participants with Adverse Events

  1,3,6 ,12, 24 and 36 months or more after treatment

Study Arms (2)

prednisone plus cyclophosphamide

EXPERIMENTAL

prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day\*6 months) plus cyclophosphamide(1g intravenous use,per 1 month\*6months)

Drug: prednisone plus cyclophosphamide

prednisone alone

EXPERIMENTAL

prednisone alone: prednisone(0.5mg/kg/day\*6 months)

Drug: Prednisone alone

Interventions

prednisone plus cyclophosphamide DRUG

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

prednisone plus cyclophosphamide

Prednisone alone DRUG

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

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 Officials

• wei shi, MD PhD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: January 1, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 14, 2017

Record last verified: 2017-07

Locations

CN (1)