MedTrace Logo

Eculizumab Therapy for Dense Deposit Disease and C3 Nephropathy

NCT01221181 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-02-19

Study results available
· View outcomes & findings →

Summary

This open label, non-blinded, proof of concept efficacy and safety study of eculizumab in patients with biopsy proven DDD or C3 nephropathy. The trial will consist of adult patients with these diseases who have \> 1 gram of proteinuria or a decreased glomerular filtration rate (GFR), both predictors of a poor long-term outcome in many glomerular diseases. The patients will be treated with eculizumab for one year.

The goals will be to determine whether treatment leads to an improvement in kidney function, defined by remissions of proteinuria and improvements in estimated GFR (measured by serum creatinine), and to improvement in histologic parameters, including percentage of non-affected glomeruli, interstitial fibrosis, intensity of C3 staining of immunofluorescence, and amount of electron dense deposits by electron microscopy.

Conditions

  • Dense Deposit Disease
  • Membranoproliferative Glomerulonephritis

Interventions

DRUG

Eculizumab

Dosage/Frequency: 900 mg IV once a week for 4 weeks, 1200 mg IV week 5, then 1200 mg IV every 2 weeks through week 53.

Sponsors & Collaborators

Principal Investigators

  • Gerald B Appel, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-10-31
Completion
2011-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221181 on ClinicalTrials.gov