Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease With or Without Comorbidities

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT06794996
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Proteinuric Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 67 Years
Healthy Volunteers
Not accepted

Interventions

  • Inaxaplin — DRUG
    Tablets for Oral Administration.

Study Details

The purpose of the study is to evaluate the efficacy, safety, and tolerability of Inaxaplin (IXP) in participants with proteinuric APOL1- mediated kidney disease (AMKD).

Key Dates

First listed
Jan 27, 2025
Start date
Feb 4, 2025
Status verified
Nov 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IXP (Inaxaplin)
    Participants with proteinuric APOL1-mediated kidney disease (AMKD) with or without the comorbidity of Type 2 diabetes mellitus (T2DM) will receive a single dose of IXP once daily, for 13 weeks.

Primary Outcome Measure

Percent Change in Urine Albumin-Creatinine Ratio (UACR) [ Time Frame: Baseline and At Week 13 ]

Locations (35)

FacilityCityStateZIPSite coordinators
Nephrology Consultants, LLCHuntsvilleAlabama35805-
Foundation for Sickle Cell Disease Research, LLCHollywoodFlorida33023-
South Florida Research InstituteLauderdale LakesFlorida33313-
Schiff Center for Liver DiseasesMiamiFlorida33136-
CTR Oakwater, LLCOrlandoFlorida32806-
Renal Associates, LLCColumbusGeorgia31904-
Georgia Nephrology - DecaturDecaturGeorgia30030-
Javara Inc./Privia Medical Group Georgia, LLC - FayettevilleFayettevilleGeorgia30214-
Georgia NephrologyLawrencevilleGeorgia30046-
Javara Inc. /Privia Medical Group Georgia, LLC - SavannahSavannahGeorgia31406-
Renal Associates of Baton RougeBaton RougeLouisiana70808-
LCMC HealthMetairieLouisiana70006-
Ochsner Medical Center - New Orleans - NephrologyNew OrleansLouisiana70121-
Northwest Louisiana Nephrology, LLC - ShreveportShreveportLouisiana71101-
Javara Inc./Privia Medical Group, LLC MidAtlantic-Silver Spring, MDSilver SpringMaryland20901-
Nephrology Associates, P.C.ColumbusMississippi39705-
Nephrology and Hypertension Associates, LTDTupeloMississippi38801-
DaVita Kidney Care - Las VegasLas VegasNevada89107-
Rutgers Doctors Office CenterNewarkNew Jersey07103-
Saint Michael's Medical Center - Peter Ho Memorial ClinicNewarkNew Jersey07102-
Scott Research, Inc.LaureltonNew York11413-
NYC Health + Hospital/HarlemNew YorkNew York10037-
North Carolina Nephrology P.A. - Cary OfficeCaryNorth Carolina27511-
UNC Clinical and Translational Research CenterChapel HillNorth Carolina27599-7155-
Duke University Hospital - Children's Health CenterDurhamNorth Carolina27710-
Eastern Nephrology Associates - New Bern OfficeNew BernNorth Carolina28562-
Lewis Katz School of Medicine at Temple University - Section of NephrologyPhiladelphiaPennsylvania19140-
Columbia Nephrology Associates, PAColumbiaSouth Carolina29203-
Carolina Nephrology, PASpartanburgSouth Carolina29306-
Dallas Nephrology Associates - Dallas Landry OfficeDallasTexas75246-
Dallas Renal Group - 1DallasTexas75237-
Dallas Renal Group - 2DallasTexas75230-
UTSW Medical Center - NephrologyDallasTexas75390-
Prolato Clinical Research CenterHoustonTexas77054-
Tks Research, P.L.L.C.NorfolkVirginia23504-

Find similar trials in Huntsville, AL

By research site
Nephrology Consultants, LLC· Huntsville, ALFoundation for Sickle Cell Disease Research, LLC· Hollywood, FLSouth Florida Research Institute· Lauderdale Lakes, FLSchiff Center for Liver Diseases· Miami, FLCTR Oakwater, LLC· Orlando, FLRenal Associates, LLC· Columbus, GA

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