End Stage Renal Disease

Nephrology
30
Pipeline Programs
24
Companies
50
Clinical Trials
2 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
5
12
1
4
6
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
150%
Small Molecule
150%
+ 42 programs with unclassified modality

On Market (3)

Approved therapies currently available

Veloxis Pharmaceuticals
ENVARSUS XRApproved
tacrolimus
Veloxis Pharmaceuticals
oral2015
Astellas
PROGRAFApproved
tacrolimus
Astellas
oral2018
Amgen
SENSIPARApproved
cinacalcet hydrochloride
Amgen
oral2004

Competitive Landscape

24 companies ranked by most advanced pipeline stage

Rockwell Medical
10 programs
2
4
1
2
1
Triferic AVNUPhase 41 trial
SFPPhase 31 trial
TrifericPhase 31 trial
Soluble Ferric Pyrophosphate in liquid bicarbonatePhase 21 trial
TrifericPhase 1/21 trial
+5 more programs
Active Trials
NCT02636049CompletedEst. Oct 2015
NCT02739100CompletedEst. Jul 2016
NCT04409132CompletedEst. Apr 2021
+7 more trials
Veloxis Pharmaceuticals
2 programs
1
1
TacrolimusPhase 2/31 trial
EnvarsusN/A1 trial
Active Trials
NCT03703154CompletedEst. Mar 2021
NCT03321656RecruitingEst. Mar 2026
Amgen
AmgenTHOUSAND OAKS, CA
2 programs
2
1
AMG 223Phase 22 trials
SENSIPAR(Cinacalcet)Phase 25 trials
Active Trials
NCT00756860Completed66Est. Sep 2009
NCT00530114Completed167Est. Feb 2009
NCT00113958Completed
+4 more trials
Astellas
AstellasChina - Shenyang
2 programs
1
1
Tacrolimus Extended-Release Oral CapsulePhase 41 trial
RoxadustatPhase 2Small Molecule1 trial
Active Trials
NCT01147666Completed161Est. Oct 2012
NCT03194321Completed20Est. Oct 2020
CSL Behring
CSL BehringIL - Bradley
1 program
1
CMVIGPhase 41 trial
Active Trials
NCT00784979Completed26Est. Apr 2012
Dynavax Technologies
Dynavax TechnologiesCA - Emeryville
1 program
1
HEPLISAVPhase 31 trial
Active Trials
NCT01195246Completed155Est. Aug 2012
Abbott
AbbottABBOTT PARK, IL
1 program
1
PAL-40 ActivePhase 31 trial
Active Trials
NCT00032435Completed2,003Est. Sep 2006
Aronora
AronoraOR - Portland
2 programs
2
AB002 Dose 1Phase 21 trial
AB023- Dose 1Phase 21 trial
Active Trials
NCT03963895Completed40Est. Dec 2020
NCT03612856Completed27Est. Jul 2019
GS
Gilead SciencesFOSTER CITY, CA
2 programs
2
EpclusaPhase 21 trial
EpclusaPhase 2
Active Trials
NCT04075916Completed201Est. Feb 2026
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
1 program
1
Empagliflozin 10 MGPhase 21 trial
Active Trials
NCT05786443Recruiting60Est. Dec 2026
LeMaitre Vascular
LeMaitre VascularAustralia - Docklands
1 program
1
Expedial Vascular Access GraftPhase 21 trial
Active Trials
NCT00131872TerminatedEst. Nov 2006
Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
High dose IVIG and B cell depleting agentsPhase 21 trial
Active Trials
NCT01502267Unknown2Est. Jan 2016
Pfizer
PfizerNEW YORK, NY
1 program
1
SirolimusPhase 21 trial
Active Trials
NCT01595841Completed17Est. Mar 2022
M&
Merck & Co.RAHWAY, NJ
1 program
1
ZepatierPhase 1/21 trial
Active Trials
NCT02743897Completed62Est. Dec 2022
Outset Medical
Outset MedicalSAN JOSE, CA
3 programs
Intermittent Non-InvasiveBlood Pressure MonitorN/A1 trial
Tablo Hemodialysis SystemN/A1 trial
Tablo Hemodialysis SystemN/A1 trial
Active Trials
NCT05540457Completed10Est. Feb 2024
NCT02460263Completed30Est. May 2019
NCT04526301Unknown500Est. Jul 2024
Xeltis
XeltisNetherlands - Eindhoven
3 programs
Xeltis Hemodialysis AccessN/A1 trial
aXessN/A1 trial
aXess-E conduitN/A1 trial
Active Trials
NCT06494631Enrolling By InvitationEst. Jan 2032
NCT04898153Active Not RecruitingEst. Sep 2027
NCT06329310RecruitingEst. Dec 2026
Rein Therapeutics
2 programs
Daily hemodialysis at low dialysate flowN/A1 trial
No systematic monitoring of symptomsN/A1 trial
Active Trials
NCT01845012TerminatedEst. Jan 2015
NCT06257134RecruitingEst. Dec 2026
Sanofi
SanofiPARIS, France
2 programs
Rabbit Antithymocyte globulinN/A2 trials
sevelamer hydrochlorideN/A1 trial
Active Trials
NCT00859131Completed200Est. Jul 2014
NCT00782821Completed40Est. Mar 2013
NCT01049815Completed175Est. Feb 2009
Merit Medical
Merit MedicalSOUTH JORDAN, UT
1 program
HeRO® Graft System or Super HeRO® SystemN/A1 trial
Active Trials
NCT06422871Recruiting100Est. Dec 2028
Deka Biosciences
Deka BiosciencesMD - Germantown
1 program
HemoCare™ Hemodialysis SystemN/A1 trial
Active Trials
NCT04198012CompletedEst. Apr 2024
Rhythm Pharmaceuticals
1 program
Reveal LINQ™ Insertable Cardiac MonitorN/A1 trial
Active Trials
NCT02275923Terminated9Est. Jul 2015
Design Therapeutics
1 program
Sixty deviceN/A1 trial
Active Trials
NCT04623281CompletedEst. Jun 2021
Novartis
NovartisBASEL, Switzerland
1 program
TACROLIMUS(Tacrolimus)N/A5 trials
Active Trials
NCT03781414Terminated129Est. Apr 2023
NCT03663335Completed418Est. Oct 2021
NCT03413722Completed30Est. Oct 2022
+2 more trials
Genentech
GenentechCA - Oceanside
1 program
rituximabN/AMonoclonal Antibody1 trial
Active Trials
NCT00167791Withdrawn0Est. Mar 2008

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Rockwell MedicalTriferic AVNU
AstellasTacrolimus Extended-Release Oral Capsule
NovartisTacrolimus
NovartisTacrolimus
NovartisTacrolimus
SanofiRabbit Antithymocyte globulin
NovartisTacrolimus
AmgenCinacalcet
NovartisTacrolimus
NovartisTacrolimus
NovartisTacrolimus
AmgenCinacalcet
NovartisTacrolimus
NovartisTacrolimus
NovartisTacrolimus

Showing 15 of 49 trials with date data

Clinical Trials (50)

Total enrollment: 8,125 patients across 50 trials

Triferic AVNU Infusion Via Freedom Pump During Hemodialysis

Start: Apr 2021Est. completion: Jun 2021
Phase 4Completed
NCT03194321AstellasTacrolimus Extended-Release Oral Capsule

Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients

Start: Sep 2017Est. completion: Oct 202020 patients
Phase 4Completed

Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients

Start: Oct 2012Est. completion: Aug 201573 patients
Phase 4Completed

Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation

Start: Jan 2011Est. completion: Jan 201559 patients
Phase 4Completed

Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients

Start: Oct 2010Est. completion: May 201171 patients
Phase 4Completed
NCT00782821SanofiRabbit Antithymocyte globulin

Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients

Start: Sep 2008Est. completion: Mar 201340 patients
Phase 4Completed

Kidney Biopsy Controlled Trial of Calcineurin Inhibitor Withdrawal

Start: Jan 2008Est. completion: Dec 201158 patients
Phase 4Completed

A Study of Cinacalcet to Improve Achievement of National Kidney Foundation Kidney Disease Outcomes Quality Initiative (K/DOQI) Targets in Patients With End Stage Renal Disease (ESRD)

Start: Sep 2006Est. completion: Oct 200971 patients
Phase 4Completed

Steroid Free Immunosuppression in Liver Transplantation

Start: Feb 2006Est. completion: Jun 200840 patients
Phase 4Completed

Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus

Start: Jan 2006361 patients
Phase 4Terminated

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

Start: Jun 2004Est. completion: May 200839 patients
Phase 4Completed

A Research Study for Patients With End-Stage Renal Disease (ESRD)

Start: May 2004Est. completion: Sep 2007552 patients
Phase 4Completed

Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion

Start: Feb 2004Est. completion: Oct 200550 patients
Phase 4Terminated

Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant

Start: Feb 2004Est. completion: Dec 200539 patients
Phase 4Completed

Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients

Start: Oct 2003Est. completion: Mar 2006693 patients
Phase 4Completed

Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients

Start: Dec 2002Est. completion: Dec 2007171 patients
Phase 4Completed

Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation

Start: Jan 2002Est. completion: Apr 201226 patients
Phase 4Completed

Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)

Start: Sep 2020Est. completion: Nov 2023
Phase 3Unknown

Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis

Start: Jun 2015Est. completion: Mar 201728 patients
Phase 3Completed

Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

Start: Nov 2014Est. completion: Jun 201655 patients
Phase 3Terminated

Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis

Start: Nov 2011Est. completion: Jan 2014
Phase 3Completed

Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis

Start: Dec 2010Est. completion: Aug 2012155 patients
Phase 3Completed

Cinacalcet HCl in Chronic Kidney Disease Subjects With Secondary Hyperparathyroidism Not Receiving Dialysis

Start: Oct 2004400 patients
Phase 3Completed

SENSOR: Study to Investigate Cinacalcet Treatment in Haemodialysis Patients With Secondary Hyperparathyroidism

Start: Sep 2004Est. completion: Feb 2006673 patients
Phase 3Completed
NCT00032435AbbottPAL-40 Active

Homocysteine Study (HOST)

Start: May 2001Est. completion: Sep 20062,003 patients
Phase 3Completed

Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

Start: Mar 2019Est. completion: Mar 2026
Phase 2/3Recruiting

Cinacalcet Study to Reach Kidney Disease Outcomes Quality Initiative (K/DOQI) Levels

Phase 2Completed

Safety and Efficacy of Empagliflozin in Hemodialysis

Start: Jan 2024Est. completion: Dec 202660 patients
Phase 2Recruiting

A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients

Start: Jun 2021Est. completion: Feb 2026201 patients
Phase 2Completed

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension

Start: Oct 2019Est. completion: Apr 2023129 patients
Phase 2Terminated
NCT03963895AronoraAB002 Dose 1

Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis

Start: Jul 2019Est. completion: Dec 202040 patients
Phase 2Completed

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

Start: Nov 2018Est. completion: Oct 2021418 patients
Phase 2Completed
NCT03612856AronoraAB023- Dose 1

Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis

Start: Oct 2018Est. completion: Jul 201927 patients
Phase 2Completed

Sirolimus Use in Angioplasty for Vascular Access Extension

Start: Dec 2011Est. completion: Mar 202217 patients
Phase 2Completed
NCT01286012Rockwell MedicalSoluble Ferric Pyrophosphate in liquid bicarbonate

Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients

Start: Jan 2011Est. completion: Jan 2013
Phase 2Completed

Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis

Start: May 2010Est. completion: Oct 2012161 patients
Phase 2Completed

Efficacy, Safety, Tolerability, Pharmacokinetics of Sotrastaurin-tacrolimus vs. Mycophenolic Acid-tacrolimus in de Novo Liver Transplant Patients

Start: Apr 2010Est. completion: Jul 2012200 patients
Phase 2Completed
NCT01502267RocheHigh dose IVIG and B cell depleting agents

Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant

Start: Jan 2010Est. completion: Jan 20162 patients
Phase 2Unknown

Efficacy, Safety, Tolerability, and Pharmacokinetics of Sotrastaurin Combined With Tacrolimus vs. a Mycophenolic Acid-tacrolimus Regimen in Renal Transplant Patients

Start: Dec 2009Est. completion: Aug 2012298 patients
Phase 2Completed

Study to Assess Fixed Dosing of AMG 223 in Subjects With Chronic Kidney Disease on Hemodialysis With Hyperphosphatemia

Start: Mar 2008Est. completion: Feb 2009167 patients
Phase 2Completed

24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients

Start: Oct 2007Est. completion: Mar 2008137 patients
Phase 2Terminated

Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease

Start: May 2006Est. completion: May 2011110 patients
Phase 2Completed
NCT00131872LeMaitre VascularExpedial Vascular Access Graft

Study to Evaluate the Performance and Safety of Expedial and Compare it to Expanded Polytetrafluoroethylene (ePTFE) Vascular Access Grafts

Start: Mar 2004Est. completion: Nov 2006
Phase 2Terminated

Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)

Start: Jul 2003360 patients
Phase 2Completed

Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.

Start: Jun 2020Est. completion: Apr 2021
Phase 1/2Completed

A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

Start: Sep 2019Est. completion: Jan 2020
Phase 1/2Completed

Equivalence of Triferic® (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

Start: Oct 2017Est. completion: Dec 2017
Phase 1/2Completed

Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients

Start: May 2016Est. completion: Dec 202262 patients
Phase 1/2Completed

Triferic Pediatric Pharmacokinetic Protocol

Start: Nov 2015Est. completion: Jan 2017
Phase 1/2Completed

CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

Start: Feb 2015Est. completion: Nov 201759 patients
Phase 1/2Completed

Related Jobs in Nephrology

Phase Legend

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

Key Insights

4 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 8,125 patients
24 companies competing in this space