A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601(siplizumab) Compared to Anti-Thymocyte Globulin (rATG), as Induction Therapy in de novo Renal Transplant Recipients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507895-36-00

Acronym

TCD601B101

Enrollment

Registered

2024-02-07

Start date

2021-06-06

Completion date

2024-12-11

Last updated

2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Brief summary

Adverse events (AEs), Serious adverse events (SAEs), Clinically significant changes in clinical chemistry, hematology, vital signs, serology, Siplizumab PK, Immunophenotyping, CD2 receptor occupancy (RO), Estimated glomerular filtration rate (eGFR) via Modification of Diet in Renal Disease (MDRD) equation., Anti-siplizumab antibodies

Detailed description

Immunophenotyping via fluorescence-activated cell sorting (FACS)., Lymphocyte counts, CD2 RO, Incidence of tBPAR, de novo-DSA / anti-human leukocyte antigen (HLA) antibody measurement, Incidence of AMR, eGFR

Interventions

DRUGCetirizina Mylan 10 mg comprimidos revestidos por película

DRUGPrednisolone 5mg Soluble Tablets

DRUGTHYMOGLOBULINE 5 mg/ml

DRUGpoeder voor oplossing voor infusie

DRUGThymoglobuline

DRUGpulver til infusionsvæske

DRUGopløsning

DRUGAdport 0

DRUG5 mg

DRUGcapsules

DRUGhard

DRUGCellCept 250 mg capsules

DRUGThymoglobuline 5 mg/ml

DRUGPulver zur Herstellung einer Infusionslösung.

DRUGParacetamol 500 mg Film Coated Tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adverse events (AEs), Serious adverse events (SAEs), Clinically significant changes in clinical chemistry, hematology, vital signs, serology, Siplizumab PK, Immunophenotyping, CD2 receptor occupancy (RO), Estimated glomerular filtration rate (eGFR) via Modification of Diet in Renal Disease (MDRD) equation., Anti-siplizumab antibodies	—

Secondary

Measure	Time frame
Immunophenotyping via fluorescence-activated cell sorting (FACS)., Lymphocyte counts, CD2 RO, Incidence of tBPAR, de novo-DSA / anti-human leukocyte antigen (HLA) antibody measurement, Incidence of AMR, eGFR	—

Countries

Austria, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026