Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Calliditas Therapeutics AB
Study ID
NCT06712407
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TARPEYO® — DRUG
    6-months of TARPEYO® 16 mg QD then 9-month Treatment Period with TARPEYO® 8 mg QD and TARPEYO®4 mg QD for 2 weeks for tapering.

Study Details

The goal of this clinical trial is to assess the efficacy and safety of extended TARPEYO® (delayed-release budesonide capsules) treatment in adult patients with primary IgA nephropathy who have completed 9 months of TARPEYO® 16 mg once daily treatment in real-world clinical practice. The main question it aims to answer is: Is there a treatment benefit of TARPEYO® 16 mg QD extended use? Participants will * take part in this study for about 19 months * Have urine tests done * Have blood samples taken * Have physical examinations done

Key Dates

Start date
Dec 17, 2024
Status verified
Feb 2026
Primary completion
May 29, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 16 mg QD then 8 mg QD
    6-months of TARPEYO® 16 mg QD then 9-month Treatment Period with TARPEYO® 8 mg QD and TARPEYO®4 mg QD for 2 weeks for tapering.

Primary Outcome Measure

Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline [ Time Frame: 6 months ]

Central Contacts

Locations (37)

FacilityCityStateZIPSite coordinators
Univ of Alabama/BirminghamBirminghamAlabama35297
Principal Investigator
Arizona Kidney Disease & Hypertension Centers (AKDHC)GlendaleArizona85306
Principal Investigator
The Medical Research Group, Inc.FresnoCalifornia93720
Mackenzie Moreno
[email protected]
559-228-6600
Harpreet Dhindsa (PRINCIPAL_INVESTIGATOR)
UCI Health-UCI Medical CenterOrangeCalifornia92868
Principal Investigator
Loma Linda UniversitySan BernardinoCalifornia92408
Amber Jarvis
[email protected]
909-558-5830
Sayna Norouzi (PRINCIPAL_INVESTIGATOR)
UCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty PracticeSan FranciscoCalifornia94143
PI
Stanford UniversityStanfordCalifornia94305
Principal Investigator
University of Colorado Hospital (UCH) - Kidney Disease and Hypertension Clinic - Anschutz Medical Campus LocationAuroraColorado80045
Principal Investigator
Yale University Nephrology Clinical Trials ProgramNew HavenConnecticut06510
Principal Investigator
Florida Kidney PhysiciansBoca RatonFlorida33431
Principal Investigator
Central Florida Kidney SpecialistsOrlandoFlorida32819
Principal Investigator
Southeastern Clinical Research Institute, LLCAugustaGeorgia30904
Principal Investigator
Cobb Nephrology Hypertension Associates, PCAustellGeorgia30106
Principal Investigator
Georgia NephrologyLawrencevilleGeorgia30046
Julie Scoggin
[email protected]
804-467-3158
James Tumlin (PRINCIPAL_INVESTIGATOR)
University of LouisvilleLouisvilleKentucky40208
Jory Goff
[email protected]
574-382-0102
Gunjan Garg (PRINCIPAL_INVESTIGATOR)
Ochsner Health, New OrleansNew OrleansLouisiana70121
Principal Investigator
University of Maryland Division of NephrologyBaltimoreMaryland21201
Hema Venkatesh
[email protected]
410-706-4111
Preeti Chandra (PRINCIPAL_INVESTIGATOR)
Boston Medical Center; Boston University Chobanian & Avedisian School of MedicineBostonMassachusetts02118
Kemberlie Adolphe
[email protected]
617- 414-7075
Ashish Upadhyay (PRINCIPAL_INVESTIGATOR)
University of Minnesota Health FairviewMinneapolisMinnesota55455
Ben Tang
[email protected]
612-301-3382
Nattawat Klomjit (PRINCIPAL_INVESTIGATOR)
Washington University in St. LouisSt LouisMissouri63130
Principal Investigator
Renal Medical AssociatesAlbuquerqueNew Mexico87109
Principal Investigator
University of New MexicoAlbuquerqueNew Mexico87106
Principal Investigator
New York Nephrology Vasculitis and Glomerular CenterClifton ParkNew York12065
Tatiana Cordero
[email protected]
518-434-2244
Frank Cortazar (PRINCIPAL_INVESTIGATOR)
Chinatown Kidney Care, PLLCNew YorkNew York10013
Principal Investigator
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Principal Investigator
North Carolina Nephrology, P.ARaleighNorth Carolina27609
Mallory Phillips
[email protected]
919-231-3966
Michael Casey (PRINCIPAL_INVESTIGATOR)
Ohio State UniversityColumbusOhio43210
Principal Investigator
Oregon Health & Science University (OHSU) - Nephrology and Hypertension ClinicPortlandOregon97239
Principal Investigator
University of Pennsylvania PhiladelphiaPhiladelphiaPennsylvania19104
Principal Investigator
Dallas Renal GroupDallasTexas75230
Principal Investigator
MedResearch IncEl PasoTexas79902
Principal Investigator
The University of Texas Medical Branch UTMBGalvestonTexas77555
Principal Investigator
Memorial Hermann HoustonHoustonTexas77054
Principal Investigator
Prolato Clinical Research CenterHoustonTexas77054
Principal Investigator
The Kidney Institute/HoustonHoustonTexas77090
Principal Investigator
Dallas Nephrology Associates McKinneyMcKinneyTexas75069
Principal Investigator
Permian Basin Kidney CenterOdessaTexas79761
Principal Investigator

Find similar trials in Birmingham, AL

By research site
Univ of Alabama/Birmingham· Birmingham, ALArizona Kidney Disease & Hypertension Centers (AKDHC)· Glendale, AZThe Medical Research Group, Inc.· Fresno, CAUCI Health-UCI Medical Center· Orange, CALoma Linda University· San Bernardino, CAUCSF Health-UCSF Medical Center-Parnassus - Nephrology and Hypertension Faculty Practice· San Francisco, CA

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