Who is sponsoring NCT00522548?

NCT00522548 is sponsored by University of Pennsylvania.

What drugs are being tested in NCT00522548?

Interventions in NCT00522548: Enteric coated mycophenolate sodium, Mycophenolate mofetil.

What condition does NCT00522548 study?

NCT00522548 studies Transplants and Implants.

Is NCT00522548 still recruiting?

NCT00522548 is currently terminated. Last updated 20 December 2017.

Are results published for NCT00522548?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-12-20 · How we verify

NCT00522548

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

Gastrointestinal Adverse Effect Outcomes of De Novo African American Kidney Transplant Recipients Treated With Tacrolimus, Corticosteroids and Mycophenolate Mofetil or Enteric Coated Mycophenolate Sodium

Terminated Phase 4 Results posted Last updated 20 December 2017

What this trial tests

Phase 4 trial testing Enteric coated mycophenolate sodium in Transplants and Implants in 37 participants. Terminated before completion.

Timeline

1 March 2007

Primary endpoint
1 January 2011

1 January 2011

Quick facts

Lead sponsor	University of Pennsylvania
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	1 March 2007
Primary completion	1 January 2011
Estimated completion	1 January 2011
Sites	1 location across United States

Drugs / interventions tested

Enteric coated mycophenolate sodium — full drug profile →
Mycophenolate mofetil (MYCOPHENOLATE MOFETIL) — full drug profile →

Conditions studied

Transplants and Implants — all drugs for Transplants and Implants →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 75, any sex, with Transplants and Implants. 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.

Gastrointestinal Toxicity Due to Enteric Coated Mycophenolate Sodium or Mycophenolate Mofetil or Its Generic Equivalent Formulation Manufactured by Sandoz
Time frame: 6 months
At 24 weeks, we assessed the number of patients at this timepoint who required permanent dose decrease or discontinuation of either enteric coated mycophenolate sodium or mycophenolate mofetil or its generic equivalent formulation manufactured by Sandoz related to gastrointestinal toxicity.

Sponsor's own description

Myfortic (enteric-coated mycophenolate sodium) has been shown to have similar effectiveness to CellCept (mycophenolate mofetil) in preventing rejection in kidney transplant recipients. However, enteric coated mycophenolate sodium has been thought to possibly be associated with fewer gastrointestinal side effects. Mycophenolate mofetil and enteric coated mycophenolate sodium pharmacokinetics (how the drug is absorbed and broken down) have not been well-studied in African American kidney transplant recipients. The investigators are interested in studying enteric coated mycophenolate sodium and mycophenolate mofetil pharmacokinetics and gastrointestinal side effects in African American kidney transplant recipients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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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 NCT00522548 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
Last refreshed: 20 December 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/NCT00522548.

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