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

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ClinicalTrials.gov Identifier: NCT03703908
Recruitment Status : Unknown
Verified June 2019 by ChemoCentryx.
Recruitment status was:  Recruiting
First Posted : October 12, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

Tracking Information
First Submitted Date  ICMJE July 24, 2018
First Posted Date  ICMJE October 12, 2018
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 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 primary FSGS and nephrotic syndrome as assessed by changes in UPCR
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2018)
  • Changes from baseline in EKG values [ Time Frame: Baseline to each subsequent clinic visit through week 52 ]
    Triplicate EKGs assessed for any clinically significant abnormalities as determined by the relevant PIs evaluation
  • Changes from baseline in blood pressure [ Time Frame: Baseline to each subsequent clinic visit through week 52 ]
    Assessment of systolic and diastolic BP changes from baseline
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
Official Title  ICMJE An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Intervention Model Description:
Open-Label, Intra-Subject, Dose Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Focal Segmental Glomerulosclerosis
Intervention  ICMJE Drug: CCX140-B
Orally administered tablet
Study Arms  ICMJE Experimental: Sequential
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: 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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
13
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03703908
Other Study ID Numbers  ICMJE CL012_140
LUMINA-2 ( Other Identifier: Chemocentryx )
Has Data Monitoring Committee No
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 Not Provided
Investigators  ICMJE
Study Director: Peter Staehr, M.D. ChemoCentryx
PRS Account ChemoCentryx
Verification Date June 2019

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