Clinical trial NCT03703908: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Focal Segmental Glomerulosclerosis
Keywords: FSGS
Glomerulosclerosis
Proteinuria
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-10-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Open-Label, Intra-Subject, Dose Escalation
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The Number of Subjects With a Reduction in Urine Protein to Creatinine Ratio (UPCR) of at Least 20%
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Achievement of Partial or Complete Remission of UPCR Through Week 12 and Through the End of Treatment
timeFrame: Baseline to week 12
measure: Proportion of Subjects With Achievement of Complete Remission During the Treatment Period
timeFrame: Baseline to week 52
measure: Time Taken of Subjects to Achieve Complete Remission During the Treatment Period
timeFrame: Baseline to week 52
measure: Change From Baseline in Urine Protein:Creatinine Ratio (UPCR) Over Time
timeFrame: Baseline to week 12 and week 52
measure: Assessment of Time to and Proportion of Subjects With Achievement of Partial Remission During the Treatment Period
timeFrame: Baseline to week 52
measure: Time to Rescue Therapy
timeFrame: Baseline to week 52
measure: Mean Change From Baseline for eGFR Using the CKD-EPI Cystatin C Equation Over Time
timeFrame: Baseline to Week 12 and Week 52
measure: Mean Change From Baseline for the eGFR CKD-EPI Creatinine Equation Over Time
timeFrame: Baseline to Week 12 and Week 52
measure: Mean Change From Baseline for eGFR CKD-EPI Creatinine-Cystatin C Equation Over Time
timeFrame: Baseline to Week 12 and Week 52
measure: Mean Change From Baseline for the MDRD Creatinine Equation Over Time
timeFrame: Baseline to Week 12 and Week 52
measure: Effect of CCX140-B Treatment on Quality of Life Endpoint SF-36V2
timeFrame: Baseline to Week 52
measure: Effect of CCX140-B Treatment on Quality of Life Endpoint EQ-5D-5L for the Overall Trial
timeFrame: Baseline to Week 12 and Week 52
measure: Changes to Laboratory Parameters Related to Renal Function Including Serum Albumin, Creatinine, Cystatin C, Urinary Albumin:Creatinine Ratio, Total 24-hour Protein Excretion During the Trial
timeFrame: Baseline to Day 57
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute
state: California
city: Shreveport
country: United States
facility: Northwest Louisiana Nephrology
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Salt Lake City
country: United States
facility: Utah Kidney Research Institute
state: Utah
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: