Renal Insufficiency

Nephrology
24
Pipeline Programs
11
Companies
50
Clinical Trials
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
21
0
1
0
1
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
267%
Peptide
133%
+ 22 programs with unclassified modality

On Market (1)

Approved therapies currently available

J&
INVOKAMET XRApproved
canagliflozin and metformin hydrochloride
Johnson & Johnson
oral2016

Competitive Landscape

11 companies ranked by most advanced pipeline stage

J&
Johnson & JohnsonNEW BRUNSWICK, NJ
1 program
1
1
INVOKAMET XR(Canagliflozin)Phase 1Small Molecule5 trials
Active Trials
NCT04288778Completed276Est. Jul 2022
NCT03604224Completed178Est. Jul 2019
NCT03492580Completed714,582Est. Jun 2018
+2 more trials
Biogen
BiogenCAMBRIDGE, MA
2 programs
1
1
tonapofyllinePhase 31 trial
TonapofyllinePhase 21 trial
Active Trials
NCT00745316Terminated34Est. Jan 2010
NCT00709865Completed420Est. Dec 2009
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
9 programs
9
Afatinib healthyPhase 11 trial
BI 1015550Phase 11 trial
BI 1467335Phase 11 trial
BI 207127Phase 11 trial
BI 425809Phase 11 trial
+4 more programs
Active Trials
NCT02096718Completed30Est. Dec 2014
NCT05718648Completed26Est. Aug 2023
NCT03302091Completed20Est. Aug 2018
+6 more trials
M&
Merck & Co.RAHWAY, NJ
4 programs
4
MK-0822Phase 13 trials
MK-7145Phase 11 trial
Midazolam oral solutionPhase 11 trial
PegIFN-2bPhase 13 trials
Active Trials
NCT01512693Completed17Est. Apr 2012
NCT01512667Completed25Est. Aug 2012
NCT00397683Terminated2Est. Apr 2007
+5 more trials
Pfizer
PfizerNEW YORK, NY
3 programs
1
Aztreonam-AvibactamPhase 11 trial
FragminN/A1 trial
Pharmacokinetics of Dalteparin in Patients With Impaired Renal FunctionN/A1 trial
Active Trials
NCT00138099Completed140Est. Jun 2006
NCT00264693Completed96Est. May 2008
NCT04486625Completed11Est. Oct 2021
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
LY3819469Phase 11 trial
Active Trials
NCT05841277Completed26Est. Jan 2024
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
1 program
1
LanabecestatPhase 1Small Molecule
Guerbet
GuerbetFrance - Villepinte
1 program
1
P03277Phase 11 trial
Active Trials
NCT03657784Completed40Est. Aug 2019
Novartis
NovartisBASEL, Switzerland
1 program
1
QAW039Phase 11 trial
Active Trials
NCT03087942Completed45Est. Aug 2018
Rhythm Pharmaceuticals
1 program
1
SetmelanotidePhase 1Peptide1 trial
Active Trials
NCT04348175Completed32Est. Apr 2021
Medicure
MedicureBarbados - Holetown
1 program
1
TirofibanPhase 11 trial
Active Trials
NCT01766154CompletedEst. Mar 2013

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Johnson & JohnsonCanagliflozin
Johnson & JohnsonCanagliflozin
Johnson & JohnsonCanagliflozin
Merck & Co.PegIFN-2b
Johnson & JohnsonCanagliflozin
Johnson & JohnsonCanagliflozin
Johnson & JohnsonCanagliflozin
Biogentonapofylline
BiogenTonapofylline
Merck & Co.MK-0822
Eli Lilly and CompanyLY3819469
Boehringer IngelheimBI 1015550
Boehringer IngelheimBI 425809
PfizerAztreonam-Avibactam
Rhythm PharmaceuticalsSetmelanotide

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 5,396 patients across 50 trials

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes

Start: Nov 2020Est. completion: Jul 2022276 patients
Phase 4Completed

An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

Start: Oct 2017Est. completion: Oct 201864 patients
Phase 4Completed

Treatment of Diabetes in Patients With Systolic Heart Failure

Start: Oct 2016Est. completion: Sep 201836 patients
Phase 4Completed

A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

Start: Jan 2014Est. completion: Dec 20150
Phase 4Withdrawn

A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise

Start: Jun 2013Est. completion: Dec 20141,186 patients
Phase 3Completed

The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

Start: Jul 2010Est. completion: Mar 2012756 patients
Phase 3Completed

CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride

Start: Sep 2009Est. completion: Jan 20131,452 patients
Phase 3Completed
NCT00709865Biogentonapofylline

Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency

Start: Jul 2008Est. completion: Dec 2009420 patients
Phase 3Completed
NCT00745316BiogenTonapofylline

Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency

Start: Feb 2009Est. completion: Jan 201034 patients
Phase 2Terminated

A 52-Week Study to Assess the Effects of MK0822 on Knee Osteoarthritis (MK-0822-011)

Start: Oct 2006Est. completion: Apr 20072 patients
Phase 2Terminated

A Study of LY3819469 in Participants With Impaired and Normal Renal Function

Start: Apr 2023Est. completion: Jan 202426 patients
Phase 1Completed

A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems

Start: Feb 2023Est. completion: Aug 202326 patients
Phase 1Completed

A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Kidney Problems

Start: Feb 2023Est. completion: Oct 202336 patients
Phase 1Completed
NCT04486625PfizerAztreonam-Avibactam

Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment

Start: Aug 2020Est. completion: Oct 202111 patients
Phase 1Completed

A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment

Start: Jul 2020Est. completion: Apr 202132 patients
Phase 1Completed
NCT03311841Merck & Co.Midazolam oral solution

Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)

Start: Mar 2018Est. completion: Aug 201832 patients
Phase 1Completed

A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 1467335 is Processed in the Body

Start: Oct 2017Est. completion: Aug 201820 patients
Phase 1Completed

Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function

Start: Oct 2017Est. completion: Aug 201940 patients
Phase 1Completed

Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects

Start: Jul 2017Est. completion: Aug 201845 patients
Phase 1Completed

A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants

Start: Aug 2016Est. completion: Oct 201644 patients
Phase 1Completed

A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants

Start: Aug 2016Est. completion: Oct 201644 patients
Phase 1Completed

A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release (XR) With Respect to Metformin XR Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants

Start: Aug 2016Est. completion: Nov 201644 patients
Phase 1Completed

Bioequivalence Study of Metformin Component of Canagliflozin and Metformin Fixed Dose Combination Immediate Release (IR) Tablet Comparing With Metformin IR Tablet Co-administered With Canagliflozin Tablet in Healthy Fed and Fasted Participants

Start: Aug 2014Est. completion: Oct 20142 patients
Phase 1Completed

Bioequivalence Study of Metformin Component of Fixed Dose Combination (FDC) Immediate Release (IR) Tablet of Canagliflozin and Metformin Compared to Metformin IR Tablet Co-administered With Canagliflozin in Healthy Fed and Fasted Participants

Start: Aug 2014Est. completion: Nov 20142 patients
Phase 1Completed

Afatinib in Subjects With Kidney Dysfunction

Start: May 2014Est. completion: Dec 201430 patients
Phase 1Completed

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants

Start: Mar 2014Est. completion: Jul 201447 patients
Phase 1Completed

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

Start: Feb 2014Est. completion: Jun 201452 patients
Phase 1Completed

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants

Start: Feb 2014Est. completion: May 20143 patients
Phase 1Completed

A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

Start: Feb 2014Est. completion: Apr 20142 patients
Phase 1Completed

Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food

Start: Jan 2014Est. completion: Mar 201424 patients
Phase 1Completed

Multiple Dose Pharmacokinetics of Canagliflozin/Metformin 150/1,000 mg Fixed Dose Combination

Start: Jan 2014Est. completion: Mar 201412 patients
Phase 1Completed

Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients

Start: Oct 2013Est. completion: Dec 20134 patients
Phase 1Terminated

The Pharmacokinetics of MK-7145 Following Single Dose Administration in Participants With Moderate Renal Insufficiency (MK-7145-018)

Start: Aug 2013Est. completion: Dec 20130
Phase 1Withdrawn

A Study to Compare the Pharmacodynamics of Canagliflozin and Dapagliflozin in Healthy Volunteers

Start: Jul 2013Est. completion: Mar 201460 patients
Phase 1Completed

Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function

Start: Jan 2013Est. completion: Mar 2013
Phase 1Completed

Assessment of Pharmacokinetics of Single Dose Odanacatib (MK-0822) in Participants With Moderate Hepatic Insufficiency (MK-0822-070)

Start: Feb 2012Est. completion: Apr 201217 patients
Phase 1Completed

Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)

Start: Jan 2012Est. completion: Aug 201225 patients
Phase 1Completed

A Study of Canagliflozin and Metformin Immediate Release (50 mg/500 mg) FDC Tablets in Healthy Volunteers

Start: Jan 2012Est. completion: Mar 201264 patients
Phase 1Completed

A Study of Canagliflozin and Metformin Immediate Release (150 mg/500 mg) FDC Tablets in Healthy Volunteers

Start: Jan 2012Est. completion: Mar 201264 patients
Phase 1Completed

Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)

Start: Nov 2011Est. completion: Aug 201225 patients
Phase 1Completed

Effect of Food on a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Volunteers

Start: Oct 2011Est. completion: Dec 201124 patients
Phase 1Completed

A Study to Assess the Bioequivalence of Fixed Dose Combination (FDC) Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

Start: Sep 2011Est. completion: Jan 201283 patients
Phase 1Completed

A Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) With Respect to the Individual Components of Canagliflozin and Metformin IR Tablets in Healthy Volunteers

Start: Sep 2011Est. completion: Dec 201174 patients
Phase 1Completed

A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Start: Aug 2011Est. completion: Oct 201114 patients
Phase 1Completed

A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers

Start: Jul 2011Est. completion: Aug 201114 patients
Phase 1Completed

A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers

Start: Mar 2011Est. completion: Jul 201130 patients
Phase 1Completed

A Study to Assess the Effects of Cyclosporine on the Pharmacokinetics and Safety of Canagliflozin (JNJ-28431754) in Healthy Volunteers

Start: Feb 2011Est. completion: Apr 201118 patients
Phase 1Completed

A Study of Two Methods for Determining the Renal Threshold for Glucose in Patients With Type 2 Diabetes Mellitus

Start: Jan 2011Est. completion: Jul 201128 patients
Phase 1Completed

A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers

Start: Jan 2011Est. completion: May 201134 patients
Phase 1Completed

A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers

Start: Dec 2010Est. completion: Feb 201118 patients
Phase 1Completed

Related Jobs in Nephrology

Phase Legend

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

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
11 companies competing in this space