Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance
Public ClinicalTrials.gov record NCT00400400. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 4-week, Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group Study to Compare the Gastrointestinal Safety and Tolerability of EC-MPS & MMF When Administered in Combination With Calcineurin Inhibitors in Renal Transplant Recipients Experiencing Gastrointestinal Intolerance
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).
Study identification
- NCT ID
- NCT00400400
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
- Enteric-coated mycophenolate sodium (EC-MPS) Drug
- Mycophenolate mofetil Drug
- Placebo to mycophenolate sodium Drug
- Placebo to mycophenolate mofetil Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2006 (Type not available)
- Primary completion
- Jun 2008 (Actual)
- Completion
- Not listed
- Last update posted
- Aug 15, 2011
Started 2006
United States locations
- U.S. sites
- 53
- U.S. states
- 31
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AKDHC Medical Research Services, LLC | Phoenix | Arizona | 85012 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| National Institute of Transplantation | Los Angeles | California | 90057 | — |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| University of California San Diego | San Diego | California | 92103-8401 | — |
| University of California, San Diego | San Diego | California | 92103 | — |
| University of California | San Francisco | California | 94143 | — |
| Denver Nephrology | Denver | Colorado | 80218 | — |
| University of Colorado Health Science Center | Denver | Colorado | 80262 | — |
| Yale University Transplantation | New Haven | Connecticut | 06520 | — |
| Washington Hospital Transplant Research | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610-0224 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| Medical College of Georgia | Augusta | Georgia | 30912 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Clarian Health Partners | Indianapolis | Indiana | 46202 | — |
| Univ of KS Medical Ctr | Kansas City | Kansas | 64111 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | — |
| Northwest Louisiana Nephrology Research | Shreveport | Louisiana | 71101 | — |
| WKHS/LSUHSC Regional Transplant Center | Shreveport | Louisiana | 71103 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21205 | — |
| Mid-Atlantic Nephrology Associates | Baltimore | Maryland | 21228 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| St. John Hospital Medical Center | Detroit | Michigan | 48236 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| St. Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| St. Baranabas Medical Center | Livingston | New Jersey | 07039 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599-7211 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Wake Forest | Winston-Salem | North Carolina | 27157 | — |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oregon Health & Science University | Portland | Oregon | 97239-3098 | — |
| Pinnacle Health at Harrisburg Hospital | Harrisburg | Pennsylvania | 17105 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| The University of Tennessee Health Science Center | Memphis | Tennessee | 38104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2372 | — |
| CRSTI | Dallas | Texas | 75230 | — |
| Baylor All Saints | Fort Worth | Texas | 76104 | — |
| University of Texas Medical Branch | Galveston | Texas | 77555-0533 | — |
| University of Utah Hospitals and Clinics | Salt Lake City | Utah | 84132 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| University of Washington | Seattle | Washington | 98195-6521 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00400400, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 15, 2011 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00400400 live on ClinicalTrials.gov.