NCT00229138 is a Phase 4 clinical trial of EC-MPS, Tacrolimus in Kidney Transplantation, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT00229138?

NCT00229138 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT00229138?

Interventions in NCT00229138: EC-MPS, Tacrolimus.

What condition does NCT00229138 study?

NCT00229138 studies Kidney Transplantation.

Is NCT00229138 still recruiting?

NCT00229138 is currently completed. Last updated 3 February 2017.

Last reviewed 2017-02-03 · How we verify

NCT00229138

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

A Six-month, Prospective, Multicenter, Open Label, Parallel, Randomized Study of the Safety, Tolerability and Efficacy of EC-MPS With Basiliximab, Corticosteroids and Two Different Levels of Tacrolimus in de Novo Renal Transplant Recipients

Completed Phase 4 Last updated 3 February 2017

What this trial tests

Phase 4 trial testing EC-MPS, Tacrolimus in Kidney Transplantation in 291 participants. Completed in 1 March 2007.

Timeline

1 September 2005

Primary endpoint
1 March 2007

1 March 2007

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	291
Start date	1 September 2005
Primary completion	1 March 2007
Estimated completion	1 March 2007
Sites	1 location across United States

Drugs / interventions tested

EC-MPS, Tacrolimus — full drug profile →

Conditions studied

Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 70, any sex, with Kidney Transplantation.

What's being measured

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

renal function at 6 months posttransplant as measured by glomerular filtration rate
Time frame: 6 months

Sponsor's own description

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Renal Function and NODM in De Novo Renal Transplant Recipients Treated with Standard and Reduced Levels of Tacrolimus in Combination with EC-MPS.
Chan L, Andres A, Bunnapradist S, Gugliuzza K, et al · · 2012 · cited 12× · PMID 23227307 · DOI 10.1155/2012/941640

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 Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

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 NCT00229138 (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 Novartis Pharmaceuticals
Last refreshed: 3 February 2017

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/NCT00229138.

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