NCT00717470 (OSAKA) is a Phase 4 clinical trial of Prograf® in Kidney Transplantation, sponsored by Astellas Pharma Inc.

Who is sponsoring NCT00717470?

NCT00717470 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT00717470?

Interventions in NCT00717470: Prograf®, Advagraf®, Mycophenolate Mofetil, Simulect, methylprednisolone / prednisone.

What condition does NCT00717470 study?

NCT00717470 studies Kidney Transplantation.

Is NCT00717470 still recruiting?

NCT00717470 is currently completed. Last updated 1 November 2024.

Last reviewed 2024-11-01 · How we verify

NCT00717470: OSAKA

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

A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection

Completed Phase 4 Last updated 1 November 2024

What this trial tests

Phase 4 trial testing Prograf® in Kidney Transplantation in 1,252 participants. Completed in 2 March 2010.

Timeline

14 May 2008

Primary endpoint
2 March 2010

2 March 2010

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,252
Start date	14 May 2008
Primary completion	2 March 2010
Estimated completion	2 March 2010
Sites	110 locations across Italy, Ireland, Poland, Netherlands, Russia, Belgium, Sweden, Portugal

Drugs / interventions tested

Prograf®
Advagraf®
Mycophenolate Mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →
Simulect — full drug profile →
methylprednisolone / prednisone

Conditions studied

Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

18 and older, any sex, with Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To compare how well the new formulation of Tacrolimus® used once daily, in combination with other drugs helps prevent the rejection of a new kidney after transplantation compared to the twice daily dose of Tacrolimus

Publications & conference data

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

OSAKA trial: a randomized, controlled trial comparing tacrolimus QD and BD in kidney transplantation.
Albano L, Banas B, Klempnauer JL, Glyda M, et al · · 2013 · cited 59× · PMID 23982340 · DOI 10.1097/tp.0b013e3182a203bd
Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials.
Krämer BK, Albano L, Banas B, Charpentier B, et al · · 2017 · cited 9× · PMID 29149958 · DOI 10.1016/j.transproceed.2017.07.011
A Novel, Dose-Adjusted Tacrolimus Trough-Concentration Model for Predicting and Estimating Variance After Kidney Transplantation.
Kim J, Wilson S, Undre NA, Shi F, et al · · 2019 · cited 4× · PMID 31073875 · DOI 10.1007/s40268-019-0271-2
Outcomes with Tacrolimus-Based Immunosuppression After Kidney Transplantation from Standard- and Extended-Criteria Donors - A Post Hoc Analysis of the Prospective OSAKA Study.
Albano L, Banas B, Lehner F, Glyda M, et al · · 2020 · cited 2× · PMID 32467559 · DOI 10.12659/aot.920041

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 NCT00717470 (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: 1 November 2024

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/NCT00717470.

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