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A Study of CCX140-B in Subjects With FSGS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03536754
Recruitment Status : Active, not recruiting
First Posted : May 25, 2018
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Medpace, Inc.
Information provided by (Responsible Party):
ChemoCentryx

Tracking Information
First Submitted Date  ICMJE March 28, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
Changes from baseline in urine protein to creatinine ratio (UPCR) [ Time Frame: Baseline to week 12 ]
Effect of CCX140-B on treatment of urinary protein excretion in subjects with FSGS as assessed by changes from baseline in UPCR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
  • Changes from baseline in renal function as assessed by changes in eGFR using several equations (see description) [ Time Frame: Baseline to weeks 12 and 24 ]
    Effect of CCX140-B on renal function as assessed by eGFR using the CKD-EPI Cystatin C, CKD-EPI creatinine equation, CKD-EPI creatinine-cystatin c equation and NDRD creatinine equation
  • Changes in PK profile as measured by Auc0-6 at steady state at intervals throughout the treatment period [ Time Frame: Baseline to weeks 12 and 24 ]
    Effect of CCX140-B on the PK profile in subjects with FSGS
  • Changes in PK profile as measured by Cmin at intervals throughout the treatment period [ Time Frame: Baseline to weeks 12 and 24 ]
    Evaluation of the PK profile of CCX140-B in subjects with FSGS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CCX140-B in Subjects With FSGS
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Focal Segmental Glomerulosclerosis (FSGS)
Brief Summary A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with FSGS to be conducted in the North America, Europe and Australia
Detailed Description A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects with Focal Segmental Glomerulosclerosis (FSGS) to be conducted in the North America, Europe and Australia. The aim of this study is to evaluate the effect of treatment with CCX140-B, a selective antagonist of C-C chemokine receptor type 2 in subjects with focal segmental glomerulosclerosis on urinary protein excretion as assessed by changes in urine protein to creatinine ratio (UPCR)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Randomized, placebo-controlled, Phase 2
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind
Primary Purpose: Treatment
Condition  ICMJE
  • FSGS
  • Focal Segmental Glomerulosclerosis
  • Glomerulosclerosis
Intervention  ICMJE
  • Other: Placebo
    Placebo
    Other Name: CCX140-B Placebo
  • Drug: CCX140-B
    CCX140-B is an orally administered selective antagonist of CCR2
Study Arms  ICMJE
  • Placebo Comparator: Group A
    Placebo (N=10)
    Intervention: Other: Placebo
  • Experimental: Group B
    CCX140-B 5 mg once daily (N=10)
    Intervention: Drug: CCX140-B
  • Experimental: Group C
    CCX140-B 10 mg twice daily (N=10)
    Intervention: Drug: CCX140-B
  • Experimental: Group D
    CCX140-B 15 mg twice daily (N=10)
    Intervention: Drug: CCX140-B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 19, 2019)
46
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2018)
40
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects aged 18-75
  2. UPCR ≥ 1 g protein/g creatinine (or at 113 mg.mmol) at screening
  3. Diagnosis of FSGS based on renal biopsy or high risk genetic variant
  4. Diagnosis of one of primary FSGS based on characteristic histopathology, medical history and clinical course or FSGS secondary to genetic variants associated with increased risk or severity.
  5. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2
  6. Clinical stable blood pressure not to exceed 145/95 mmHg
  7. RAAS blockers must be stable for at least 4 weeks prior to screening and projected to remain stable through week 12, unless adjustments are required for management of hypertension.
  8. Immunosuppressive or immunomodulatory therapy must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12
  9. Glucocorticoids must be stable for at least 4 weeks prior to screening and projected to remain stable through study week 12.
  10. Both genders of childbearing potential must agree to use adequate contraception during and for at least 3 months after the last dose of study drug.
  11. Subjects must be willing and able to give written Informed Consent and to comply with protocol requirements.
  12. Subjects must be judged to be otherwise fit for the study by the Investigator. -

Exclusion Criteria:

  1. Pregnant or nursing
  2. History of organ transplantation
  3. On an organ transplant waiting list or anticipated organ transplant within 6 months of screening
  4. Anti-CD20 monoclonal antibodies within 20 months of screening are exclusionary. Subjects that used anti CD20 monoclonal antibodies prior to week 20 are allowed with confirmed recovery of CD20+ B cell population to within normal range
  5. Plasmapheresis within 12 weeks of screening
  6. BMI ≥40
  7. Participation in any clinical study of an investigational product within 12 weeks or 5 half-lives of screening
  8. Currently on dialysis or likely to require dialysis during the blinded treatment phase of the study.
  9. History or presence of any form of cancer within 5 years of screening except excised basal cell or squamous cell carcinoma or carcinoma in situ such as cervical or breast carcinoma in situ that has been excised or completed resected without evidence or recurrence.
  10. Positive HBV, HCV, or HIV viral screening test. Subjects who have received highly effective therapy for HCV demonstrated to have negative viral titers for at least 6 months following discontinuation of treatment, will be considered to have a negative HCV screening test
  11. Renal disease associated with disorders other than FSGS that is active or has significant risk of progressing during the course of the study.
  12. Disorders that are associated with FSGS lesions.
  13. Evidence of tuberculosis.
  14. Evidence of hepatic disease with the exception that isolated INR elevation in the absence of other significant liver enzyme abnormalities is explained by anticoagulant therapy, (e.g. warfarin)
  15. Hematologic abnormalities as follows: Hb <8 g/dL, platelets <50,000, ANC <1000 cells/µL) at baseline.
  16. QTcF greater than 450 msec.
  17. History of alcohol or illicit drug abuse or of lithium, pamidronate and interferon. Recreational use of cannabis is not excluded where legal.
  18. History of gastrointestinal conditions that may interfere with study medication compliance.
  19. Known hypersensitivity to CCX140-B or inactive ingredients of the CCX140-B tablets (including microcrystalline cellulose, starch, crospovidone, magnesium stearate, or silicon dioxide).
  20. History or presence of systemic disorder other than FSGS that requires, or is expected to require, systemic glucocorticoids or immune modulators during the study; topical or inhaled glucocorticoids and immune modulators are not excluded.
  21. History or presence of any medical condition or disease which, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation.
  22. Subjects taking strong CYP3A4 inducers or strong CYP3A4 inhibitors within two weeks prior to screening.
  23. Subjects taking lithium or interferon; subjects taking non-steroidal anti-inflammatory agents (NSAIDS) chronically (intermittent, i.e. occasional NSAIDS for pain or fever is discouraged, but is not excluded).

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   France,   Italy,   New Zealand,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03536754
Other Study ID Numbers  ICMJE CL011_140
LUMINA-1 ( Other Identifier: Chemocentryx )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ChemoCentryx
Study Sponsor  ICMJE ChemoCentryx
Collaborators  ICMJE Medpace, Inc.
Investigators  ICMJE
Study Director: Peter Staehr, MD ChemoCentryx
PRS Account ChemoCentryx
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP