NCT01442337 is a Phase 2/Phase 3 clinical trial of ASP8597 in Kidney Transplantation, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT01442337?

NCT01442337 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT01442337?

Interventions in NCT01442337: ASP8597, Placebo.

What condition does NCT01442337 study?

NCT01442337 studies Kidney Transplantation.

Is NCT01442337 still recruiting?

NCT01442337 is currently terminated. Last updated 17 June 2014.

Last reviewed 2014-06-17 · How we verify

NCT01442337

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2/3, Double-Blind, Placebo-Controlled, Two-Part Study (Part 1 Open-Label) to Assess the Safety, Efficacy and Pharmacokinetics of Single Intravenous Doses of ASP8597 (Diannexin) in de Novo Kidney Transplant Recipients

Terminated Phase 2/Phase 3 Last updated 17 June 2014

What this trial tests

Phase 2/Phase 3 trial testing ASP8597 in Kidney Transplantation in 21 participants. Terminated before completion.

Timeline

1 December 2011

Primary endpoint
1 July 2013

1 July 2013

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 2/Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	21
Start date	1 December 2011
Primary completion	1 July 2013
Estimated completion	1 July 2013
Sites	19 locations across United States

Drugs / interventions tested

ASP8597 — full drug profile →
Placebo

Conditions studied

Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

Adults 18 to 70, any sex, with Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Pharmacokinetic (PK) variable for ASP8597: Maximum concentration (Cmax)
Time frame: 3 days
Part 1 PK variable
Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
Time frame: 3 days
Part 1 PK variable
Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: 3 days
Part 1 PK variable
Estimated glomerular filtration rate (eGFR) using abbreviated Modified Diet in Renal Disease (MDRD) formula - Part 2
Time frame: 12 months
Part 2 efficacy variable

Sponsor's own description

The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

The future of marginal kidney repair in the context of normothermic machine perfusion.
DiRito JR, Hosgood SA, Tietjen GT, Nicholson ML. · · 2018 · cited 55× · PMID 29878499 · DOI 10.1111/ajt.14963
Therapeutic Potential of Annexins in Sepsis and COVID-19.
Mui L, Martin CM, Tschirhart BJ, Feng Q. · · 2021 · cited 26× · PMID 34566657 · DOI 10.3389/fphar.2021.735472
Acute Kidney Injury (AKI) before and after Kidney Transplantation: Causes, Medical Approach, and Implications for the Long-Term Outcomes.
Palmisano A, Gandolfini I, Delsante M, Cantarelli C, et al · · 2021 · cited 26× · PMID 33918444 · DOI 10.3390/jcm10071484

Verify or expand the search:

Other recruiting trials for Kidney Transplantation

Currently open trials in the same condition.

NCT07275632 — The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients · Phase 1, PHASE2 · recruiting
NCT06568549 — Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective · Phase 4 · recruiting
NCT06829719 — TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation · NA · recruiting
NCT07316829 — TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Re · active not recruiting
NCT06886256 — Prehabilitation for Kidney Transplant Candidates · NA · recruiting

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01442337 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 17 June 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01442337.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing