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

Phase 2TerminatedNCT03703908

Amgen5 enrolled

Overview

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

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. Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Focal Segmental Glomerulosclerosis

Interventions

CCX140-BDRUG

Orally administered tablet

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female subjects aged 18 years and older 2. 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 3. Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening Exclusion Criteria: 1. Pregnant or nursing 2. History of organ transplantation, including renal transplantation 3. Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening 4. Histological FSGS subtype of collapsing variant 5. 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. 6. 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. 7. Body Mass Index (BMI) ≥ 40

Locations (5)

Los Angeles Biomedical Research Institute

Torrance, California, United States

Northwest Louisiana Nephrology

Shreveport, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%

Number of subjects with a reduction in Urine Protein to Creatinine Ratio (UPCR) of at least 20% , i.e., ≥20%, by Week 12.

Time frame: Baseline to week 12

Secondary Outcomes

Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment

Partial and complete remission were defined as follows: Partial remission (included all of the following): * Reduction from baseline by ≥50% in urine protein:creatinine ratio (UPCR) * Reduction in UPCR to a level that was \<3.5 g/g * Subject could not have been a treatment failure Complete remission (included all of the following): * Reduction in UPCR to \<0.3 g/g * Serum albumin within normal range * For subjects with abnormal serum creatinine levels at baseline, return to normal levels * For subjects with normal serum creatinine levels at baseline, final value within 20% of baseline levels * Subject could not have been a treatment failure

Time frame: Baseline to week 12

Proportion of Subjects With Achievement of Complete Remission During the Treatment Period

Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to \<0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.

Time frame: Baseline to week 52

Time Taken of Subjects to Achieve Complete Remission During the Treatment Period

Complete remission is defined as reduction in urine protein:creatinine ratio (UPCR) to \<0.3 g/g, normal serum albumin, and normal serum creatinine levels or within 20% of baseline levels.

Time frame: Baseline to week 52

Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time

Mean change from baseline in urinary protein:creatinine ratio (UPCR) over time.

Data from ClinicalTrials.gov

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