TrialReader

A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation

NCT06365437 — Phase 2, Terminated, 33 participants, ITB-Med LLC
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT06365437
StatusTerminated - After enrolment was complete, and sufficient data was collected to fully characterize the highest dose cohort, study follow up was terminated by the sponsor for non-safety related reasons.
PhasePhase 2
Study typeInterventional; randomized, sequential, masking: none, basic science
Enrollment33 (Actual)
SponsorITB-Med LLC (Industry)
ConditionsKidney Transplantation
InterventionsTCD601, Tacrolimus (TAC), Corticosteroids (CS), Mycophenolate Mofetil (MMF), ATG (Biological, drug)
Datesstart 2021-06-06, primary completion 2024-12-11, completion 2024-12-11, first posted 2024-04-15, last updated 2026-03-12
Locations7 sites in Austria, Spain, Sweden

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Kidney Transplantation All trials of TCD601 All trials of Tacrolimus (TAC)

-Summary

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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Arm 1ExperimentalBiological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF)TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 2ExperimentalBiological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF)TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 3ExperimentalBiological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF)TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 4ExperimentalBiological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF)TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Arm 5Active comparatorDrug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF); Drug: ATGATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
  • TCD601 (Biological), also known as Siplizumab: Investigational Product
  • Tacrolimus (TAC) (Drug): Standard of Care Concomitant Immunosuppression
  • Corticosteroids (CS) (Drug): Standard of Care Concomitant Immunosuppression
  • Mycophenolate Mofetil (MMF) (Drug): Standard of Care Concomitant Immunosuppression
  • ATG (Drug): Standard of Care induction therapy in solid organ transplantation

+Outcome measures

Primary outcomes

  • Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0. [12 months]
  • Measure Peak TCD601 Plasma Concentration (Cmax) Over Time. [12 months]: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
  • Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC). [12 months]: The AUC from time zero to the last measurable concentration sampling time.

Secondary outcomes

  • The Incidence of Allograft Rejection at 12 Months Post-Transplant [12 months]
  • To Assess Renal Function Over Time [12 months]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Able to understand the study requirements and provide written informed consent before and study assessment is performed.
* Male or female patients ≥ 18 to 70 years of age.
* Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor.
* Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.

Exclusion Criteria:

* Multiple-organ transplant recipients
* Subjects who have received a kidney allograft previously
* Recipient of a kidney from an HLA identical living related donor
* Recipient of a kidney from a donor after cardiac death
* Subjects at high immunological risk for rejection

+Posted results

Participant flow

MilestoneArm 1Arm 2Arm 3Arm 4Arm 5
Started65885
Completed54703
Not completed11182

Outcome results

  • Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0. (Primary), Count of participants, Participants: Arm 1 6; Arm 2 5; Arm 3 8; Arm 4 8; Arm 5 5
  • Measure Peak TCD601 Plasma Concentration (Cmax) Over Time. (Primary), Mean, ug/mL: Arm 1 4.3 +/- 0.578; Arm 2 12.8 +/- 1.96; Arm 3 50.6 +/- 9.79; Arm 4 135 +/- 11.8
  • Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC). (Primary), Mean, ug/mLxday: Arm 1 26.2 +/- 4.67; Arm 2 95.4 +/- 29.3; Arm 3 627 +/- 249; Arm 4 1910 +/- 389
  • The Incidence of Allograft Rejection at 12 Months Post-Transplant (Secondary), Count of participants, Participants: Arm 1 0; Arm 2 0; Arm 3 1; Arm 4 0; Arm 5 0
  • To Assess Renal Function Over Time (Secondary), Mean, mL/min/1.73m^2: Arm 1 32.99 +/- 15.671; Arm 2 61.8 +/- 20.521; Arm 3 51.85 +/- 12.011; Arm 4 59.45 +/- 12.676; Arm 5 51.17 +/- 8.376

Adverse events

Time frame: 12 Months

ArmDeathsSerious adverse eventsOther adverse events
Arm 10/6 (0.0%)3/6 (50.0%)6/6 (100.0%)
Arm 20/5 (0.0%)1/5 (20.0%)5/5 (100.0%)
Arm 30/8 (0.0%)4/8 (50.0%)8/8 (100.0%)
Arm 40/8 (0.0%)4/8 (50.0%)8/8 (100.0%)
Arm 50/5 (0.0%)0/5 (0.0%)5/5 (100.0%)

Serious adverse events by term

TermOrgan systemArm 1Arm 2Arm 3Arm 4Arm 5
Duodenal ulcer haemorrhageGastrointestinal disorders0/61/50/80/80/5
PancreatitisGastrointestinal disorders0/60/50/81/80/5
Transplant RejectionImmune system disorders0/60/50/81/80/5
AppendicitisInfections and infestations0/60/51/80/80/5
Pulmonary NocardiosisInfections and infestations0/60/51/80/80/5
PneuomoniaInfections and infestations0/60/51/80/80/5
Cerebral NocardiosisInfections and infestations0/60/51/80/80/5
Delayed Graft FunctionInjury, poisoning and procedural complications2/60/50/80/80/5
Graft ThrombosisInjury, poisoning and procedural complications0/60/51/80/80/5
Infusion Related ReactionInjury, poisoning and procedural complications0/60/50/81/80/5
Renal LymphoceleInjury, poisoning and procedural complications0/60/50/81/80/5
Blood Creatinine IncreasedInvestigations0/60/50/81/80/5
New onset Diabetes after transplantationMetabolism and nutrition disorders1/60/50/80/80/5
Renal Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/60/51/80/80/5
Focal Segmental GlomerulosclerosisRenal and urinary disorders1/60/50/80/80/5
HydronephrosisRenal and urinary disorders0/60/50/81/80/5
Renal ImpairmentRenal and urinary disorders1/60/50/80/80/5
Deep vein thrombosisVascular disorders0/60/51/80/80/5
HypotensionVascular disorders0/60/50/81/80/5
LymphoceleVascular disorders1/60/50/80/80/5

Other adverse events by term

TermOrgan systemArm 1Arm 2Arm 3Arm 4Arm 5
AnemiaBlood and lymphatic system disorders0/60/51/81/80/5
Iron Deficiency AnemiaBlood and lymphatic system disorders0/60/51/80/80/5
LeukopeniaBlood and lymphatic system disorders3/61/54/82/82/5
Nephrogenic AnemiaBlood and lymphatic system disorders2/60/50/80/80/5
NeutropeniaBlood and lymphatic system disorders0/60/50/81/80/5
PolycythaemiaBlood and lymphatic system disorders0/60/50/80/81/5
PalpitationsCardiac disorders0/61/51/81/80/5
TachycardiaCardiac disorders0/60/50/81/80/5
VertigoEar and labyrinth disorders1/60/51/80/80/5
Hyperparathyroidism tertiaryEndocrine disorders0/60/51/80/80/5
HypothyroidismEndocrine disorders1/60/50/80/80/5
Dry eyeEye disorders1/60/50/80/80/5
Eye painEye disorders0/60/50/80/81/5
Retinal detachmentEye disorders0/60/51/80/80/5
scleral hemorrhageEye disorders1/60/50/80/80/5
Abdominal discomfortGastrointestinal disorders0/60/51/80/80/5
Abdominal painGastrointestinal disorders2/60/51/81/80/5
Abdominal pain upperGastrointestinal disorders0/60/50/81/80/5
Aphthous ulcerGastrointestinal disorders0/60/50/81/80/5
ConstipationGastrointestinal disorders1/61/50/81/80/5
DiarrhoeaGastrointestinal disorders2/60/54/81/82/5
Faeces hardGastrointestinal disorders1/60/50/80/80/5
HaematocheziaGastrointestinal disorders0/61/50/80/80/5
HaemorrhoidsGastrointestinal disorders1/60/50/80/80/5
Intra-abdominal haematomaGastrointestinal disorders0/60/51/80/80/5
Mouth ulcerationGastrointestinal disorders0/60/51/80/80/5
NauseaGastrointestinal disorders3/60/52/80/80/5
OesophagitisGastrointestinal disorders0/60/50/81/80/5
VomitingGastrointestinal disorders1/60/53/81/80/5
chillsGeneral disorders0/60/50/80/81/5
FatigueGeneral disorders2/60/50/80/80/5
General physical health deteriorationGeneral disorders1/60/50/80/80/5
MalaiseGeneral disorders1/60/50/80/80/5
Oedema peripheralGeneral disorders3/60/52/80/80/5
PainGeneral disorders1/60/50/80/80/5
Peripheral swellingGeneral disorders0/61/50/80/80/5
Puncture site haematomaGeneral disorders0/60/50/80/81/5
PyrexiaGeneral disorders2/61/51/81/81/5
HyperbilirubinaemiaHepatobiliary disorders0/60/50/80/81/5
Transplant RejectionImmune system disorders1/60/51/80/80/5
BK virus infectionInfections and infestations3/60/51/80/81/5
Bacterial disease carrierInfections and infestations0/60/51/80/80/5
BacteriuriaInfections and infestations1/60/50/80/80/5
BronchitisInfections and infestations0/60/51/80/80/5
COVID-19Infections and infestations1/61/51/80/80/5
ConjunctivitisInfections and infestations1/60/50/80/80/5
Cytomegalovirus infectionInfections and infestations1/61/52/81/81/5
Cytomegalovirus viraemiaInfections and infestations3/60/55/81/80/5
Device related infectionInfections and infestations1/60/50/80/80/5
Epstein-Barr viraemiaInfections and infestations0/61/50/80/80/5
Epstein-Barr virus infectionInfections and infestations0/61/52/80/81/5
Genital herpesInfections and infestations0/61/50/80/80/5
Lyme diseaseInfections and infestations0/60/50/81/80/5
Nasal herpesInfections and infestations0/60/50/80/81/5
NasopharyngitisInfections and infestations3/60/53/80/81/5
Oral candidiasisInfections and infestations1/60/50/80/80/5
Oral fungal infectionInfections and infestations0/60/51/80/80/5
Oral herpesInfections and infestations2/60/50/80/81/5
Polyomavirus viraemiaInfections and infestations4/60/51/81/81/5
Postoperative wound infectionInfections and infestations0/60/51/80/80/5

113 more terms not shown.

+Locations (7)

FacilityCityCountryStatus
Innsbruck Medical UniversityInnsbruckAustria
University of ViennaViennaAustria
Hospital Clinic de BarcelonaBarcelonaSpain
Hospital Universitari de BellvitgeBarcelonaSpain
Karolinska University HospitalStockholm, HuddingeSweden
Sahlgrenska University HospitalGothenburgSweden
Skåne University HospitalMalmöSweden

+Study documents

+Investigators

My Notes