A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients… (NCT02000440) | Clinical Trial Compass
CompletedPhase 2
A Phase II, Repeat Dose, Proof of Mechanism Study of Losmapimod to Reduce Proteinuria in Patients With Focal Segmental Glomerulosclerosis (FSGS)
United States17 participantsStarted 2014-07-01
Plain-language summary
This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21 subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS) and substantive proteinuria as indicated by a Urinary protein/creatinine Up/c ratio \>=2 gram/gram (g/g) or 24 hr urine protein \>=2 g/day. Losmapimod will be orally administered twice daily over a 24-week treatment phase followed by a 12-week follow-up for safety and relapse assessments.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Subject is between 18 and 70 years of age inclusive.
* Subject has a clinical diagnosis of primary (idiopathic) focal segmental glomerulosclerosis (FSGS) as verified by renal biopsy. This must be confirmed by independent review of the histopathology report and/or biopsy specimen(s) by the study central pathologist.
* Subject will have substantive proteinuria, as indicated by a spot Up/c\>=2g/g or 24 hour urine total protein \>=2g/day.
* A female subject is eligible to participate if she is of non-childbearing potential; criteria to be considered of 'non-childbearing potential' as described in the protocol.
* A female subject is eligible to participate if she is of child-bearing potential. Females of child-bearing potential must agree to use two of the approved contraception methods listed in the protocol from 14 days before the first dose of study drug until 30 days after the last dose of study drug. Only females of child-bearing potential with negative pregnancy test, as determined by serum human chorionic gonadotropin (hCG) test at screening and urine hCG test prior to dosing at baseline visit and during the study at the indicated times, will be administered losmapimod.
* Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and is willing and able to return for all study visits.
Exclusion Criteria:
* Subject has received a live attenuated vaccine within 6 w…
What they're measuring
1
Number of Participants Meeting the Definition of Responder for Reduction in Proteinuria at the Indicated Time Points