TerminatedPhase 2

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

Stopped: Program not advancing

United States5 participantsStarted 2018-10-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects aged 18 years and older
✓. 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
✓. Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening

✕. Pregnant or nursing
✕. History of organ transplantation, including renal transplantation
✕. Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening
✕. Histological FSGS subtype of collapsing variant
✕. 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.
✕. 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.

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

Timeframe: Baseline to week 12

NCT IDNCT03703908

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-24

Results submitted2022-08-10

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female subjects aged 18 years and older
✓. 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
✓. Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at screening

✕. Pregnant or nursing
✕. History of organ transplantation, including renal transplantation
✕. Currently on an organ transplant waiting list or there's a reasonable possibility of getting an organ transplant within 6 months of screening
✕. Histological FSGS subtype of collapsing variant
✕. 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.
✕. 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.