protocolSection identificationModule nctId: NCT06365437, orgStudyIdInfo id: TCD601B101, briefTitle: A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-06-06, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: ITB-Med LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients., conditionsModule conditions: Kidney Transplantation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TCD601, interventions name: Tacrolimus (TAC), interventions name: Corticosteroids (CS), interventions name: Mycophenolate Mofetil (MMF), interventions name: ATG, outcomesModule primaryOutcomes measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0., primaryOutcomes measure: Measure Peak Plasma Concentration (Cmax) over time., primaryOutcomes measure: Measure the Area under the plasma concentration versus time curve (AUC)., secondaryOutcomes measure: Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time., secondaryOutcomes measure: Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time., secondaryOutcomes measure: Measure peripheral CD2-receptor occupancy following TCD601 administration Receptor Occupancy will be reported as the % of target saturation., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Innsbruck Medical University, status: RECRUITING, city: Innsbruck, zip: A-6020, country: Austria, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 47.26266, lon: 11.39454, locations facility: University of Vienna, status: RECRUITING, city: Vienna, zip: 1090, country: Austria, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 48.20849, lon: 16.37208, locations facility: Hospital Clinic de Barcelona, status: RECRUITING, city: Barcelona, zip: 08036, country: Spain, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Hospital Universitari de Bellvitge, status: RECRUITING, city: Barcelona, zip: 08907, country: Spain, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 41.38879, lon: 2.15899, locations facility: Karolinska University Hospital, status: RECRUITING, city: Stockholm, state: Huddinge, zip: 14157, country: Sweden, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Sahlgrenska University Hospital, status: RECRUITING, city: Göteborg, zip: 41345, country: Sweden, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Skåne University Hospital, status: RECRUITING, city: Malmö, zip: 20502, country: Sweden, contacts name: Research Coordinator, role: CONTACT, geoPoint lat: 55.60587, lon: 13.00073, hasResults: False