Kidney Transplantation

Nephrology
39
Pipeline Programs
21
Companies
50
Clinical Trials
1 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
2
10
3
8
15
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
6100%
+ 39 programs with unclassified modality

On Market (4)

Approved therapies currently available

Roche
CELLCEPTApproved
mycophenolate mofetil
Roche
oral1995
Veloxis Pharmaceuticals
ENVARSUS XRApproved
tacrolimus
Veloxis Pharmaceuticals
oral2015
U
MYCOPHENOLATE MOFETIL HYDROCHLORIDEApproved
mycophenolate mofetil
Unknown Company
injection2021
Astellas
PROGRAFApproved
tacrolimus
Astellas
oral2018

Competitive Landscape

19 companies ranked by most advanced pipeline stage

Astellas
AstellasChina - Shenyang
16 programs
1
3
6
3
AdvagrafPhase 45 trials
TacrolimusPhase 41 trial
tacrolimusPhase 41 trial
FK506MRPhase 32 trials
Prograf-XLPhase 31 trial
+11 more programs
Active Trials
NCT00902980Completed264Est. Dec 2006
NCT01771705Completed40Est. Apr 2017
NCT00189722Completed160Est. Jul 2005
+20 more trials
Novartis
NovartisBASEL, Switzerland
3 programs
1
1
1
Dopamine infusion to brain dead organ donorsPhase 41 trial
CerticanPhase 32 trials
RituximabPhase 2Monoclonal Antibody
Active Trials
NCT00504543Completed311Est. Apr 2011
NCT00098241Completed45Est. Mar 2007
NCT00115115Completed487Est. Mar 2009
Veloxis Pharmaceuticals
3 programs
3
Envarsus XRPhase 41 trial
Tacrolimus Extended Release Oral Tablet [Envarsus]Phase 41 trial
Twice-daily TacrolimusPhase 41 trial
Active Trials
NCT03266393Active Not RecruitingEst. Mar 2023
NCT03828682UnknownEst. Jun 2022
NCT04773392TerminatedEst. Feb 2024
Amgen
AmgenTHOUSAND OAKS, CA
2 programs
1
darbopoeitinPhase 41 trial
ObservationsN/A1 trial
Active Trials
NCT00110656Completed38Est. Oct 2004
NCT00204334Completed60Est. Jan 2010
CP
Chugai PharmaJapan - Tokyo
1 program
1
High Hb targetPhase 41 trial
Active Trials
NCT01817699Terminated161Est. Dec 2018
Genomics
GenomicsUK - Oxford
1 program
1
Mycophenolate MofetilPhase 41 trial
Active Trials
NCT06568549Recruiting350Est. Mar 2031
Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
mycophenolate mofetil [CellCept]Phase 41 trial
Active Trials
NCT00817687Completed66Est. Jan 2012
CSL Behring
CSL BehringIL - Bradley
2 programs
1
1
PrivigenPhase 31 trial
C1 Esterase InhibitorPhase 1/21 trial
Active Trials
NCT01134510Completed20Est. Nov 2013
NCT02374736Completed18Est. May 2019
Genentech
GenentechCA - Oceanside
3 programs
1
2
Rituximab for transplant rejectionPhase 2/3
basiliximabPhase 2/3Monoclonal Antibody1 trial
efalizumabPhase 1/2Monoclonal Antibody1 trial
Active Trials
NCT00472082Terminated5Est. Apr 2009
NCT00729768Withdrawn0
Biogen
BiogenCAMBRIDGE, MA
1 program
1
Rituximab for transplant rejectionPhase 2/31 trial
Active Trials
NCT00697996Completed20Est. Aug 2007
Heidelberg Pharma
Heidelberg PharmaGermany - Ladenburg
2 programs
1
RituximabPhase 2Monoclonal Antibody1 trial
Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant StudyN/A1 trial
Active Trials
NCT01471223Completed89Est. Aug 2017
NCT01136395Completed85Est. Jun 2019
Pfizer
PfizerNEW YORK, NY
2 programs
1
CyclosporinePhase 25 trials
sirolimusN/A1 trial
Active Trials
NCT00484094Completed209Est. Jun 2015
NCT01370343Completed12Est. Jul 2011
NCT00834496Withdrawn0Est. Jan 2010
+3 more trials
Kyowa Hakko Kirin
Kyowa Hakko KirinCA - La Jolla
2 programs
2
ASKP1240Phase 21 trial
BleselumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT01780844Completed149Est. Jan 2017
NCT02921789Completed67Est. May 2021
S
SinguleraIL - Chicago
1 program
1
Arm 1: SOCPhase 21 trial
Active Trials
NCT06552169RecruitingEst. Dec 2031
Biotest Pharmaceuticals
Biotest PharmaceuticalsGermany - Dreieich
1 program
1
CytotectPhase 21 trial
Active Trials
NCT04934527CompletedEst. Dec 2024
Bristol Myers Squibb
1 program
Belatacept in Renal Transplantation: Analyses Using Data From the Collaborative Transplant StudyN/A
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
CyclosporineN/A1 trial
Active Trials
NCT00007787CompletedEst. Mar 2004
Novo Nordisk
Novo NordiskBAGSVAERD DENMARK, Denmark
1 program
Remote ischemic conditioningN/A1 trial
Active Trials
NCT01395719Unknown220Est. Jun 2016
AB
AP BiosciencesTaiwan - Taipei
1 program
Remote ischemic conditioningN/A

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
GenomicsMycophenolate Mofetil
AstellasTacrolimus
Veloxis PharmaceuticalsTwice-daily Tacrolimus
Veloxis PharmaceuticalsTacrolimus Extended Release Oral Tablet [Envarsus]
Veloxis PharmaceuticalsEnvarsus XR
AstellasTacrolimus
AstellasTacrolimus
AstellasTacrolimus
AstellasTacrolimus
AstellasTacrolimus
AstellasTacrolimus
AstellasAdvagraf
AstellasAdvagraf
AstellasTacrolimus
AstellasTacrolimus

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 8,492 patients across 50 trials

NCT06568549GenomicsMycophenolate Mofetil

Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective, Randomized, Multicenter Trial.

Start: Jun 2025Est. completion: Mar 2031350 patients
Phase 4Recruiting

A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients

Start: Jan 2022Est. completion: Mar 202455 patients
Phase 4Completed

Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR

Start: Nov 2021Est. completion: Feb 2024
Phase 4Terminated
NCT03828682Veloxis PharmaceuticalsTacrolimus Extended Release Oral Tablet [Envarsus]

Veloxis de Novo Kidney Transplant ECSWD

Start: Jun 2019Est. completion: Jun 2022
Phase 4Unknown

Envarsus XR® in Adolescent Renal Transplant Recipients

Start: Jan 2019Est. completion: Mar 2023
Phase 4Active Not Recruiting

Clinical Outcome of Delayed or Standard Prograf Together With Induction Therapy Followed by Conversion to Advagraf in Donation After Cardiac (or Circulatory) Death (DCD) Kidney Transplant Recipients

Start: Oct 2018Est. completion: Jul 2022284 patients
Phase 4Completed

A Study to Compare the Finger Prick Whole Blood MITRA Assay Method With the Established Venepuncture Whole Blood Method for Quantitative Determination of Tacrolimus Blood Concentrations in Transplant Patients

Start: Mar 2018Est. completion: Sep 201880 patients
Phase 4Completed

Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

Start: May 2017Est. completion: Dec 201825 patients
Phase 4Completed

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

Start: Sep 2016Est. completion: Jun 2019599 patients
Phase 4Completed

To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients

Start: Mar 2016Est. completion: Dec 201731 patients
Phase 4Completed

A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients

Start: May 2015Est. completion: Jun 201720 patients
Phase 4Completed

Asian Study to Investigate Safety and Efficacy of Optimized Dosing of Advagraf in Kidney Transplantation

Start: Jun 2014Est. completion: Dec 201673 patients
Phase 4Completed

A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients

Start: Nov 2013Est. completion: Nov 2015150 patients
Phase 4Completed

A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

Start: Jul 2013Est. completion: Mar 201517 patients
Phase 4Terminated

Prospective Study to Measure Vascular Parameters (Ancillary Study of ADEQUATE)

Start: Jul 2013Est. completion: Mar 2015104 patients
Phase 4Unknown

Correcting Anemia and Native Vitamin D Supplementation in Kidney Transplant Recipients

Start: Apr 2013Est. completion: Dec 2018161 patients
Phase 4Terminated

Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

Start: Sep 2012Est. completion: Nov 2013125 patients
Phase 4Completed

A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome

Start: Jul 2012Est. completion: Aug 2017144 patients
Phase 4Completed

Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)

Start: May 2012Est. completion: Mar 2015286 patients
Phase 4Unknown

A Study to Demonstrate Safety and Efficacy of Advagraf in Patients Undergoing Kidney or Liver Transplantation in India

Start: Mar 2012Est. completion: May 201392 patients
Phase 4Completed

A Paediatric, Open, Follow up Study With Modigraf Examining Safety and Efficacy in de Novo Allograft Recipients

Start: Jun 2011Est. completion: Apr 201747 patients
Phase 4Terminated

A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation

Start: Jun 2011Est. completion: Feb 201552 patients
Phase 4Completed

A Single Center, Open-label, Randomized, Pilot Study to Evaluate the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF®, Versus Tacrolimus Twice Daily, PROGRAF® in Stable Renal Recipients

Start: Apr 2011Est. completion: Apr 2013100 patients
Phase 4Completed

A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.

Start: Mar 2011Est. completion: Sep 2013853 patients
Phase 4Completed

A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids

Start: Jan 2011Est. completion: May 20131,166 patients
Phase 4Completed

Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients

Start: Dec 2010Est. completion: Aug 2012105 patients
Phase 4Completed

Advagraf/Prograf Conversion Trial

Start: Dec 2010Est. completion: Dec 201453 patients
Phase 4Completed

A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF

Start: Sep 2010Est. completion: Feb 2013138 patients
Phase 4Completed

A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

Start: May 2010Est. completion: Oct 201213 patients
Phase 4Terminated

Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Start: Aug 2009Est. completion: Jun 201178 patients
Phase 4Completed
NCT00817687Rochemycophenolate mofetil [CellCept]

A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation

Start: Jan 2009Est. completion: Jan 201266 patients
Phase 4Completed

A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

Start: May 2008Est. completion: Aug 200950 patients
Phase 4Completed

Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Start: May 2007Est. completion: Oct 200850 patients
Phase 4Completed
NCT00452361PfizerCyclosporine

Study Evaluating of Calcineurin Inhibitors Versus Sirolimus in Renal Allograft Recipient

Start: Apr 2007Est. completion: Aug 200831 patients
Phase 4Terminated
NCT00369382PfizerCyclosporine

Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

Start: Sep 2006Est. completion: May 2010121 patients
Phase 4Completed

TACrolimus in Renal Transplantation: Individualization by Pharmacogenetic

Start: Apr 2006Est. completion: Dec 2008280 patients
Phase 4Completed

A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

Start: Apr 2006Est. completion: Oct 2008123 patients
Phase 4Completed

Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

Start: Jul 2005Est. completion: Mar 200785 patients
Phase 4Terminated
NCT00204334Amgendarbopoeitin

Effects of Anemia Correction on Vascular and Monocyte Function in Renal Transplant Recipients

Start: Jun 2005Est. completion: Jan 201060 patients
Phase 4Completed
NCT00493194PfizerCyclosporine

Fibrosis in Renal Allografts

Start: May 2005Est. completion: Jul 2007100 patients
Phase 4Unknown

Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

Start: May 2005Est. completion: Mar 2009501 patients
Phase 4Completed

Study of the Safety and Efficacy of Tacrolimus Ointment in Treating Chronic Allergic Contact Dermatitis

Start: Jul 2004Est. completion: Dec 200498 patients
Phase 4Completed
NCT00195468PfizerCyclosporine

Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus

Start: Mar 2004Est. completion: Nov 2006280 patients
Phase 4Completed
NCT00115115NovartisDopamine infusion to brain dead organ donors

Donor Dopamine and Initial Graft Function

Start: Mar 2004Est. completion: Mar 2009487 patients
Phase 4Completed

Optima: Optimizing Prograf Therapy in Maintenance Allografts II

Start: Aug 2003Est. completion: Jul 200863 patients
Phase 4Completed

Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation

Start: May 2003Est. completion: Dec 2007300 patients
Phase 4Unknown

Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Treating Pediatric Patients With Atopic Dermatitis

Start: Dec 2002Est. completion: May 2003226 patients
Phase 4Completed

Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

Start: Oct 2002Est. completion: Jan 200840 patients
Phase 4Completed

Minimizing Immunosuppression in Old for Old Kidney Transplantation

Start: Mar 2002Est. completion: Oct 200890 patients
Phase 4Completed

Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Start: Sep 2001Est. completion: Jan 2006240 patients
Phase 4Completed

Related Jobs in Nephrology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

8 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 8,492 patients
21 companies competing in this space