Drugs in development for prophylaxis of rejection in kidney-transplant recipients

Figures & data

Table 1 Summary of investigational and new agents approved for rejection prophylaxis in renal transplantation

Agent	Mechanism of action	FDA indication
Extended-release tacrolimus	Calcineurin inhibitor	Prevention of organ rejection in kidney-transplant recipients, as combination therapy with mycophenolate mofetil and corticosteroids, with or without basiliximab induction
Voclosporin	Calcineurin inhibitor	Not FDA-approved
Belatacept	Costimulation inhibitor, CTLA4 analog	Prevention of acute rejection in renal transplant recipients
ASKP1240	Costimulation inhibitor, anti-CD40 monoclonal antibody	Not FDA-approved
Alefacept*	Costimulation inhibitor, CD2-LFA3 interaction	Treatment of moderate-to-severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Tofacitinib	Janus kinase 3 inhibitor	Treatment of moderate-to-severe rheumatoid arthritis
Efalizumab*	Humanized LFA1 antibody	Management of moderate-to-severe chronic plaque psoriasis in adults
Sotrastaurin	Protein kinase C inhibitor	Not FDA-approved

Note:

* Voluntarily withdrawn from the market

Abbreviation: FDA, US Food and Drug Administration; CTLA, cytotoxic T-lymphocyte-associated protein; LFA, lymphocyte function-associated antigen; CD, cluster of differentiation.

Table 2 Active ongoing clinical trials further evaluating extended-release tacrolimus in organ transplantation

Study name	Identifier	Start date
Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf^®) + Sirolimus (Rapamune^®), Versus Extended Release Tacrolimus (Advagraf^®) + Mycophenolate Mofetil in Kidney Transplant Patients	NCT01680952	September 2012
Study Comparing in Liver Transplantation Recipients With Tacrolimus Alone Versus Tacrolimus and Sirolimus	NCT01958190	January 2011
Comparison of Standard Versus Low Dose Advagraf^® with or without Angiotensin-Converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts	NCT00933231	June 2009
Once-a-Day Immunosuppression (CISECON_a_Day)	NCT01964014	October 2013
Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients	NCT01476488	July 2011
Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily	NCT01962922	November 2013
Advagraf/Prograf Conversion Trial	NCT01410162	December 2010
Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy	NCT02221583	May 2014

Table 3 Active ongoing clinical trials further evaluating belatacept in organ transplantation

Study name	Identifier	Start date
Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in USA Renal Transplant Recipients	NCT01656343	June 2011
Safety and Efficacy of a Steroid-Free, Calcineurin Inhibitor-Free, Belatacept-Based Immunosuppressive Regimen	NCT01856257	July 2013
Pattern of Use of Belatacept in US Transplant Recipients	NCT01670058	January 2012
Patterns of Use of Belatacept: Analysis of Data from the Collaborative Transplant Study	NCT01476943	April 2012
Belatacept 3 Month Post Transplant Conversion Study	NCT02213068	July 2014
Evaluating Nulojix (Belatacept) Long-Term Safety in Transplant	NCT01386359	February 2012
Early Conversion from CNI to Belatacept in Ren al Transplant Recipients with Delayed and Slow Graft Function	NCT01837043	June 2013
Optimization of Nulojix^® (Belatacept) Usage as a Means of Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation	NCT01790594	February 2013
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix^® (Belatacept)-Based	NCT01820572	March 2013
Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response after Kidney Transplantation (BMS IM 103-309)	NCT01953120	October 2013
Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients	NCT02152345	April 2014
Belatacept in Renal Transplantation with Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores	NCT01496417	March 2012
Switch from Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients	NCT02103855	June 2014
Belatacept Early Steroid Withdrawal Trial	NCT01729494	September 2012
Belatacept Post Depletional Repopulation to Facilitate Tolerance	NCT00565773	December 2007
Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy	NCT02310867	March 2015
Belatacept in Kidney Transplantation of Moderately Sensitized Patients	NCT02130817	May 2014
Belatacept for Renal Transplant Recipients with Delayed Graft Function	NCT02134288	April 2014
Phase II Pharmacokinetics, Efficacy, and Safety of Belatacept in Pediatric Renal Transplant Recipients	NCT01791491	May 2013
Efficacy of Belatacept in Reducing DSA	NCT02078193	November 2013
Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study)	NCT02091232	May 2014
Belatacept Therapy for the Failing Renal Allograft	NCT01921218	August 2013
Prevention of Autoimmune Destruction and Rejection of Human Pancreatic Islets Following Transplantation for Insulin Dependent Diabetes Mellitus	NCT00501709	February 2004