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Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)

Primary Purpose

Focal Segmental Glomerulosclerosis

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

FG-3019

About this trial

This is an interventional treatment trial for Focal Segmental Glomerulosclerosis focused on measuring steroid resistant focal segmental glomerulosclerosis, FSGS, adolescent focal segmental glomerulosclerosis, focal segmental glomerulosclerosis

Eligibility Criteria

12 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater
Biopsy diagnosis of primary FSGS with biopsy confirmed centrally
Age less than or equal to 2 years old at onset of proteinuria
First morning urine protein/creatinine ratio (U p/c) >1 gm/gm
Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2

Exclusion Criteria:

Non-FSGS renal disease other than benign cyst; or secondary FSGS
History of organ transplantation
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV)
Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal
Hematocrit < 30%

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FG-3019

Arm Description

FG-3019 5 mg/kg

Outcomes

Primary Outcome Measures

Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications

Secondary Outcome Measures

Standard plasma and urinary PK parameters

Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids

Full Information

NCT ID

NCT00782561

First Posted

October 27, 2008

Last Updated

July 29, 2019

Sponsor

FibroGen

1. Study Identification

Unique Protocol Identification Number

NCT00782561

Brief Title

Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)

Official Title

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of FG-3019 in Adolescent and Adult Subjects With Steroid-Resistant Focal Segmental Glomerulosclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Terminated

Study Start Date

April 2008 (Actual)

Primary Completion Date

June 18, 2009 (Actual)

Study Completion Date

June 18, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

FibroGen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of FG-3019 administered over 8 weeks to adolescent and adult subjects with steroid-resistant focal segmental glomerulosclerosis (FSGS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Focal Segmental Glomerulosclerosis

Keywords

steroid resistant focal segmental glomerulosclerosis, FSGS, adolescent focal segmental glomerulosclerosis, focal segmental glomerulosclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FG-3019

Arm Type

Experimental

Arm Description

FG-3019 5 mg/kg

Intervention Type

Drug

Intervention Name(s)

FG-3019

Intervention Description

FG-3019 5 mg/kg IV given over 2 hours every 2 weeks for 8 weeks

Primary Outcome Measure Information:

Title

Safety and tolerability of FG-3019 as measured by AEs, SAEs, physical exams, lab tests, and the Treatment Satisfaction Questionnaire for Medications

Time Frame

32 weeks

Secondary Outcome Measure Information:

Title

Standard plasma and urinary PK parameters

Time Frame

32 weeks

Title

Change from baseline in urinary protein/creatinine, albumin/creatinine, albumin excretion rate, estimated glomerular filtration rate (eGFR), 24 hour urinary protein and fasting serum lipids

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 12-64 years, inclusive, and girls age 10-11 years, inclusive if Tanner stage 3 or greater Biopsy diagnosis of primary FSGS with biopsy confirmed centrally Age less than or equal to 2 years old at onset of proteinuria First morning urine protein/creatinine ratio (U p/c) >1 gm/gm Estimated glomerular filtration rate greater than or equal to 40 mL/min/1.73 m2 Exclusion Criteria: Non-FSGS renal disease other than benign cyst; or secondary FSGS History of organ transplantation History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies History of malignancy, cardiovascular disease, diabetes mellitus, sickle cell disease, multiple sclerosis, systemic lupus erythematosus, or active or recurrent serious infections (including but not limited to Hepatitis B, Hepatitis C, or HIV) Participation in studies of investigational drugs within 6 weeks prior to Day 0 or receipt of an investigational drug within 12 weeks prior to Day 0 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal Hematocrit < 30%

Facility Information:

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7155

Country

United States

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43205

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Pharmacokinetics of FG-3019 in Adolescents and Adults With Focal Segmental Glomerulosclerosis (FSGS)

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