A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS)

Genzyme

Status and phase

Completed

Phase 2

Conditions

Primary Focal Segmental Glomerulosclerosis

Treatments

Drug: Placebo

Drug: fresolimumab

Study type

Interventional

Funder types

Industry

Identifiers

U1111-1139-9082 (Other Identifier)

DRI12792 (Other Identifier)

2010-019545-25 (EudraCT Number)

GC1008FSGS03110

Details and patient eligibility

About

The primary objectives of this trial are as follows:

to compare the achievement of a partial remission (PR) or complete remission (CR) in urinary protein: creatinine ratio (Up/c ratio) in patients treated with fresolimumab versus placebo
to compare the safety profile of patients treated with fresolimumab versus placebo

The secondary objectives are as follows:

To compare the reduction in proteinuria in patients treated with fresolimumab versus placebo
To evaluate fresolimumab dose-dependent reduction in proteinuria
To compare the change in renal function (estimated glomerular filtration rate [eGFR]) in patients treated with fresolimumab versus placebo
To evaluate the multiple-dose pharmacokinetics of fresolimumab

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient's renal biopsy is consistent with the diagnosis of primary Focal Segmental Glomerulosclerosis (FSGS) including all histological subtypes.
The patient has an eGFR ≥ 30 mL/min/1.73 m2
The patient has a urinary total protein:creatinine ratio ≥ 3 mg protein/mg creatinine
In the opinion of the Investigator, the patient has steroid-resistant FSGS. The patient must have been treated for FSGS with a course of high-dose steroid therapy for a minimum of 4 weeks
The patient has been treated with an ACEi (angiotensin converting enzyme inhibitor) and/or ARB (angiotensin receptor blocker) at a stable dose for a minimum of 4 weeks prior to Visit 2 (treatment start)

Exclusion criteria

The patient has FSGS which in the Investigator's opinion is secondary to another condition
The patient has been taking prednisone at a dose > 10 mg/day (or equivalent dose of an alternative glucocorticoid) within 4 weeks prior to Visit 1 (Screening Visit).
The patient has received any other systemically administered immunosuppressive drugs (other than glucocorticoids) within 8 weeks prior to Visit 1.
The patient has received rituximab within 6 months prior to Visit 1.
The patient has a history of organ transplantation.