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. Author manuscript; available in PMC: 2017 Aug 1.
Published in final edited form as: Nat Rev Drug Discov. 2016 May 27;15(8):568–588. doi: 10.1038/nrd.2016.67

Table 1.

Selected ongoing Phase II and Phase III drug development programs for the treatment of kidney disease

Drug
(company)
MOA Hypothesized
benefit
ClinicalTrials.gov
identifier
(name)
Trial information Notes Refs
Atrasentan (AbbVie) ETA receptor antagonist Haemodynamic NCT01858532 (SONAR)
  • Phase III

  • Recruiting

  • Enrolment (estimated): n=4148

  • Completion (estimated): July 2018

Primary outcome measure: time to the first occurrence of a component of the composite creatinine doubling or ESRD 77,263
Canagliflozin (Janssen) SGLT2 inhibitor Haemodynamic NCT02065791 (CREDENCE)
  • Phase III

  • Recruiting Enrolment (estimated): n=3700

  • Completion (estimated): January 2020

Primary outcome measure: time to composite end point including ESRD, doubling of serum creatinine, renal or cardiovascular death 189
Pyridorin (NephroGenex) Vitamin B6 analogue reducing advanced glycosylation end product protein modification Antioxidant NCT02156843 (PIONEER)
  • Phase III

  • Enrolment (estimated): n=600

  • Completion (estimated): Martch 2018

Primary outcome measure:time to the composite end point (≥100% serum creatinine increase or ESRD) 290
ASP8232 (Astellas Pharma) VAP1 inhibitor Anti-inflammatory NCT02358096 (ALBUM)
  • Phase II

  • Recruiting

  • Enrolment (estimated): n=110

  • Completion (estimated): November 2016

Study aims to evaluate ASP8232 as an add-on therapy to an ACEI or an ARB in reducing albuminuria in patients withT2D and CKD 139
Baricitinib (Eli Lilly) JAK1 and JAK2 inhibition Anti-inflammatory NCT01683409
  • Phase II

  • Enrolment: n=131

  • Completed

Outcome showed an -30-40% decrease in UACR 95,105,291
CCX140 (ChemoCentryx) CCR2 antagonist Anti-inflammatory NCT01447147
  • Phase II

  • Enrolment: n=33

  • Completed

A significant (24%) reduction in first morning UACR at 12 weeks was observed 104, 292
CTP-499 (Concert Pharmaceuticals) Deuterium-containing pentoxifylline metabolite, a multi-subtype PDE inhibitor Anti-fibrotic NCT01487109
  • Phase II

  • Enrolment: n=170

  • Completed

Reportedly no significant change in UACR for patients taking CTP-499 compared with those on placebo at 24 weeks 293
Finerenone (Bayer) MBA Haemodynamic and anti-inflammatory NCT01874431
  • Phase II

  • Enrolment: n=821

  • Completed

Awaiting final data. Primary outcome change in UACR from that at baseline to that at 90 days 294, 295
GKT137831 (Genkyotex) NOX1 and NOX4 inhibitor Antioxidant NCT02010242
  • Phase II

  • Enrolment (estimated): n=200

  • Completed

Awaiting final data. Primary outcome 12-week change in UACR from baseline 296
VPI-2690B (Vascular Pharmaceuticals) Monoclonal antibody to αvβ3 integrin Inhibition of IGF1 signalling NCT02251067
  • Phase II

  • Enrolment (estimated): n=300

  • Completion (estimated): August 2017

Albuminuria reduction and eGFR preservation during the 50-week trial duration 230,232
GS-4997 (Gilead Sciences) ASK1 inhibitor Protein kinase inhibitor and anti-inflammatory NCT02177786
  • Phase II

  • Active, not recruiting

  • Enrolment (estimated): n=300

  • Completion (estimated): September 2016

Change in eGFR from baseline at week 48. UACR reduction 133
PF-04634817 (Pfizer) CCR2 and/or CCR5 antagonist Anti-inflammatory NCT01712061
  • Phase II

  • Enrolment: n=226

  • Completed

Percent reduction from baseline in UACR at week 12 -

ACEI, angiotensin-converting enzyme inhibitor; ARB, type 1 angiotensin II receptor blocker: ASK1, apoptosis signal-regulating kinase 1; CCR2. CC-chemokine receptor 2; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; ESRD, end-stage renal disease; ETA receptor, endothelin A receptor; IGF1, insulin-like growth factor 1; JAK, Janus kinase; MOA, mechanism of action; MRA, mineralocorticoid receptor antagonist; NOX, NADPH oxidase; PDE, phosphodiesterase; SGLT2, sodium–glucose co-transporter 2; T2D, type 2 diabetes; UACR, urine albumin/creatinine ratio; VAP1, vascular adhesion protein 1.