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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 : Recruiting
First Posted : October 12, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

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

Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis Drug: CCX140-B Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Open-Label, Intra-Subject, Dose Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Intra-Subject Dose Escalation Study of CCX140-B in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS) and Nephrotic Syndrome
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
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.
Drug: CCX140-B
Orally administered tablet




Primary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703908


Contacts
Contact: Erica McCluskey 650-210-2900 fsgs@chemocentryx.com
Contact: Peter Staehr, M.D. fsgs@chemocentryx.com

Locations
United States, California
Los Angeles Biomedical Research Institute Recruiting
Torrance, California, United States, 90502
United States, Louisiana
Northwest Louisiana Nephrology Recruiting
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
ChemoCentryx
Investigators
Study Director: Peter Staehr, M.D. ChemoCentryx

Additional Information:
Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT03703908     History of Changes
Other Study ID Numbers: CL012_140
LUMINA-2 ( Other Identifier: Chemocentryx )
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ChemoCentryx:
FSGS
Glomerulosclerosis
Proteinuria

Additional relevant MeSH terms:
Nephrotic Syndrome
Nephrosis
Glomerulosclerosis, Focal Segmental
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Nephritis