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A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome

Primary Purpose

Focal Segmental Glomerulosclerosis

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CCX140-B

About this trial

This is an interventional treatment trial for Focal Segmental Glomerulosclerosis focused on measuring FSGS, Glomerulosclerosis, Proteinuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female subjects aged 18 years and older
Primary FSGS based on renal biopsy findings consistent with FSGS and based on presentation of histopathology, medical history and clinical course OR subjects with genetic risk factors with presentations that are otherwise consistent with primary FSGS
Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening

Exclusion Criteria:

Pregnant or nursing
History of organ transplantation, including renal transplantation
Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening
Histological FSGS subtype of collapsing variant
Subjects who initiated, discontinued or changed dose of anti-CD20 monoclonal antibodies within 16 weeks (4 months) prior to screening are excluded. Subjects who initiated treatment with anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening are permitted if deemed safe by the investigator and only if they intend to remain on continued, unchanged therapy at a dosing interval that has been documented to achieve continuous B cell depletion for the given patient.
Subjects who discontinued Rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening without confirmed recovery of CD20+ B cell population to within normal range are excluded. Subjects who discontinued rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening with confirmed recovery of CD20+ B cell population to within normal range are permitted in the study. UPCR and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history.
Body Mass Index (BMI) ≥ 40

Sites / Locations

Los Angeles Biomedical Research InstituteRecruiting
Northwest Louisiana NephrologyRecruiting
Massachusetts General HospitalRecruiting
University of MinnesotaRecruiting
Utah Kidney Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential

Arm Description

All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily.

Outcomes

Primary Outcome Measures

Changes from baseline in urine protein to creatinine ratio (UPCR)

Effect of CCX140-B on treatment of urinary protein excretion in subjects with primary FSGS and nephrotic syndrome as assessed by changes in UPCR

Secondary Outcome Measures

Full Information

NCT ID

NCT03703908

First Posted

July 24, 2018

Last Updated

June 10, 2019

Sponsor

ChemoCentryx

1. Study Identification

Unique Protocol Identification Number

NCT03703908

Brief Title

A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome

Official Title

An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ChemoCentryx

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS and Nephrotic Syndrome

Detailed Description

An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome. The aim of this study is to explore the effect of CCX140-B, a selective antagonist of C-C chemokine receptor type 2, on proteinuria in subjects with FSGS.

6. Conditions and Keywords

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

Focal Segmental Glomerulosclerosis

Keywords

FSGS, Glomerulosclerosis, Proteinuria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Model Description

Open-Label, Intra-Subject, Dose Escalation

Masking

None (Open Label)

Enrollment

13 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sequential

Arm Type

Experimental

Arm Description

All enrolled subjects will initially be treated with the active study medication CCX140-B at a dose of 5 mg twice daily. Dose will increase in a step-wise fashion up to 15 mg twice daily.

Intervention Type

Drug

Intervention Name(s)

CCX140-B

Intervention Description

Orally administered tablet

Primary Outcome Measure Information:

Title

Changes from baseline in urine protein to creatinine ratio (UPCR)

Description

Effect of CCX140-B on treatment of urinary protein excretion in subjects with primary FSGS and nephrotic syndrome as assessed by changes in UPCR

Time Frame

Baseline to week 12

Other Pre-specified Outcome Measures:

Title

Changes from baseline in EKG values

Description

Triplicate EKGs assessed for any clinically significant abnormalities as determined by the relevant PIs evaluation

Time Frame

Baseline to each subsequent clinic visit through week 52

Title

Changes from baseline in blood pressure

Description

Assessment of systolic and diastolic BP changes from baseline

Time Frame

Baseline to each subsequent clinic visit through week 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects aged 18 years and older Primary FSGS based on renal biopsy findings consistent with FSGS and based on presentation of histopathology, medical history and clinical course OR subjects with genetic risk factors with presentations that are otherwise consistent with primary FSGS Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening Exclusion Criteria: Pregnant or nursing History of organ transplantation, including renal transplantation Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening Histological FSGS subtype of collapsing variant Subjects who initiated, discontinued or changed dose of anti-CD20 monoclonal antibodies within 16 weeks (4 months) prior to screening are excluded. Subjects who initiated treatment with anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening are permitted if deemed safe by the investigator and only if they intend to remain on continued, unchanged therapy at a dosing interval that has been documented to achieve continuous B cell depletion for the given patient. Subjects who discontinued Rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening without confirmed recovery of CD20+ B cell population to within normal range are excluded. Subjects who discontinued rituximab or other anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening with confirmed recovery of CD20+ B cell population to within normal range are permitted in the study. UPCR and other urine protein assessments up to 1 year prior to screening (if available) that were performed in these patients as part of the clinical routine should be recorded in the medical history. Body Mass Index (BMI) ≥ 40

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Erica McCluskey

Phone

650-210-2900

fsgs@chemocentryx.com

First Name & Middle Initial & Last Name or Official Title & Degree

Peter Staehr, M.D.

fsgs@chemocentryx.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Staehr, M.D.

Organizational Affiliation

ChemoCentryx

Official's Role

Study Director

Facility Information:

Facility Name

Los Angeles Biomedical Research Institute

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Individual Site Status

Recruiting

Facility Name

Northwest Louisiana Nephrology

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Individual Site Status

Recruiting

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55414

Country

United States

Individual Site Status

Recruiting

Facility Name

Utah Kidney Research Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84115

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Links:

URL

http://www.chemocentryx.com

Description

Company Website

Learn more about this trial

A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome

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