Clinical Trials Logo
  1. Home
  2. Renal Transplantation
  3. NCT05669001
  4. Details
NCT05669001 Clinical Trial

A Study of TCD601 in de Novo Renal Transplant Recipients

Renal Transplantation Clinical Trial

— ASCEND  

Official title:
A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination With Belatacept and MPA Compared to Standard of Care Immunosuppression in de Novo Renal Transplant Recipients (ASCEND)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05669001
Other study ID # TCD601B203
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 28, 2023
Est. completion date October 2026

Study information
Verified date April 2024
Source ITB-Med LLC
Contact Britain Javens, MS
Phone (212) 969-7823
Email britain.javens@itb-med.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.

Description:

The purpose of this study is to evaluate the safety and efficacy of TCD601 (siplizumab), an anti-CD2 monoclonal antibody, in combination with a CNI-free regimen of belatacept, MPA, and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date October 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key 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 ABO compatable, non-HLA identical living related donor Key Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• TCD601
Investigational Product
• belatacept
Study Product
Drug:
• ATG
Comparator
• TAC
Comparator
• MPA
Immunosuppression Therapy
• Corticosteroids
Immunosuppression Therapy

Locations
Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Health Charlottesville Virginia
United States University of Virginia Hospital Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Henry Ford Hospital Detroit Michigan
United States Inova Fairfax Hospital Medical Campus Falls Church Virginia
United States Houston Methodist Hospital Houston Texas
United States University of Kansas Medical Center Kansas City Kansas
United States Scripps Green Hospital La Jolla California
United States University of Southern California Los Angeles California
United States Loyola University Medical Center Maywood Illinois
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Mount Sinai Hospital New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Mayo Clinic Rochester Minnesota
United States University of California Davis Medical Center Sacramento California
United States Washington University in St. Louis (Barnes-Jewish Hospital) Saint Louis Missouri
United States UT Health San Antonio San Antonio Texas
United States University of California San Francisco Medical Center San Francisco California
United States Tampa General Hospital Tampa Florida
United States Atrium Health Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
ITB-Med LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2 The number of adverse events and serious adverse events 12 months
Secondary Renal function in Arm 1 compared to Arm 2 renal function using estimated glomerular filtration rate (eGFR) 12 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06026592 - Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients
Active, not recruiting NCT02444429 - 3-month Screening Biopsy to Optimize the Immunosuppression in Renal Transplantation Phase 3
Completed NCT02238418 - Efficacy of Usual Vitamin D Supplementation and Its Impact on Children and Adolescents Calciuria. Phase 4
Completed NCT01729494 - Belatacept Early Steroid Withdrawal Trial Phase 4
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2
Terminated NCT01276834 - Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation Phase 4
Completed NCT02843295 - Catalytic Antibodies to Predict Uninvasively Late Transplant Failure N/A
Completed NCT00842699 - Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab N/A
Completed NCT00525681 - Interaction Between Rimonabant and Cyclosporine and Tacrolimus Phase 4
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Completed NCT00189735 - A Study to Evaluate FK778 in Kidney Transplant Patients Phase 2
Recruiting NCT04052867 - Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy N/A
Recruiting NCT03114826 - Study of the Impact of VEGF Polymorphism on the Development of Renal Carcinoma in Renal Transplant Patients N/A
Completed NCT02587052 - A 1-year Comparison of Generic Tacrolimus (Tacni) and Prograf in Renal Transplant Patients - a Retrospective Matched Pair Analysis, GenTac
Completed NCT02020642 - Effect of Renal Transplantation on Obstructive Sleep Apnea in End Stage Renal Disease Patients (SASinTx) N/A
Completed NCT01435291 - AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation Phase 4
Recruiting NCT01001065 - Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis N/A
Completed NCT00978965 - Identification of Patients With High Probability of Poorly Responding to Therapy With Mycophenolic Acid Prodrugs
Recruiting NCT00903188 - Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation Phase 4
Completed NCT00400400 - Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance Phase 4