Clinical Trials

Clinical trials play a crucial role in advancing the science of medicine through human trials. Patients participating in clinical trials often have access to the very latest medications and protocols that may not otherwise be available. Clinical trial participants are actively contributing to the advancement of science as their participation helps perfect future treatment options for transplant patients. 

These are the current clinical trials conducted by the UM Division of Transplantation:

FDA approved for additional uses

Research Study of ATG and Rituximab in Renal Transplantation (RESTARRT) (ongoing, not recruiting)
Immunosuppression With Antithymocyte Globulin, Rituximab, Tacrolimus, Mycophenilate Mofetil and Sirolimus, Followed by Withdrawal of Immunosuppression, in Living-donor Renal Transplant Recipients

Belatacept in Renal Transplantation with Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores (ongoing, not recruiting)
A 12 Month, Single-center, Non-randomized, Open-label Study of Outcomes of Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores in de Novo Renal Transplant Recipients

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM) (TRANSFORM) (ongoing, not recruiting)
A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants (ongoing, not recruiting)
A 24 Month, Randomized, Controlled, Study to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants and Long Term Extension to Evaluate the Efficacy and Safety of Concentration-controlled Everolimus Plus Reduced Tacrolimus Compared to Standard Tacrolimus in Recipients of Living Donor Liver Transplants in Japan

Drugs currently in phase 2 or 3 testing

Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney (currently recruiting)
A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney

CCFZ533X2201 - PoC Study in de Novo Renal Transplantation (currently recruiting)
A 12-month Randomized, Multiple Dose, Open-label, Study Evaluating Safety, Tolerability, Pharmacokinetics/Pharmacodynamics (PK/PD) and Efficacy of an Anti-CD40 Monoclonal Antibody, CFZ533, in Combination With Mycophenolate Mofetil (MMF) and Corticosteroids (CS), With and Without Tacrolimus (Tac), in de Novo Renal Transplant Recipients

QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant (ReGIFT) (ongoing, currently recruiting)
A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients (ongoing, not recruiting)
A Phase 2a, Randomized, Open-label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

PKD Clinical and Translational Core Study (ongoing, currently recruiting)
The Baltimore Polycystic Kidney Disease Clinical and Translational Core Study

Studies currently in phase 4 testing

To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients (ASTOUND) (ongoing, not recruiting)
Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation

Studies to devise new tests to reduce rejection

Non Invasive Blood Test to Diagnose Acute Rejection AFTER Kidney Transplantation (DART) (ongoing, not recruiting)
Circulating Donor-Derived Cell-free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients

T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays (PROTECT) (ongoing, currently recruiting)
A Prospective Observational Trial to Evaluate the Correlation of T-SPOT® Response to CMV Infection and T Cell-mediated Acute Graft Rejection

Access (Dialysis) at Easton

A Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula (AVF) Creation in Patients With Chronic Kidney Disease (CKD) (PATENCY-1) (ongoing, not recruiting)
Multicenter, Double-Blind, Placebo-Controlled Study of PRT-201 Administered Immediately After Radiocephalic Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients (currently recruiting)
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients Implanted With the GORE® Hybrid Vascular Graft Versus Non-heparin Bonded Synthetic Vascular Grafts

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