Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
Public ClinicalTrials.gov record NCT01187953. 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
Ph3,DB/DD,Multi-Ctr,Pros,Rand Study-Efficacy and Safety of LCP-Tacro™ Tablets, QD, Compared to Prograf® Capsules,BID, in Combination With Mycophenolate Mofetil for Acute Allograft Rejection in De Novo Kidney Transplant
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will evaluate the efficacy and safety of LCP-Tacro (tacrolimus) Tablets administered once-a-day compared to Prograf (tacrolimus) Capsules twice-a-day as immunosuppression for the prevention of organ rejection in newly transplanted adult kidney transplant recipients. Patients will be treated for a 12 month study period followed by a 12 month, blinded extension treatment period To show that LCP-Tacro Tablets are clinically similar to Prograf Capsules in the prevention of acute rejection.
Study identification
- NCT ID
- NCT01187953
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 543 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 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
- Sep 2010 (Type not available)
- Primary completion
- Mar 2013 (Actual)
- Completion
- Mar 2014 (Actual)
- Last update posted
- May 18, 2016
2010 – 2014
United States locations
- U.S. sites
- 46
- U.S. states
- 22
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Site 1020 | Birmingham | Alabama | 35294 | — |
| Clinical Site 1031 | Loma Linda | California | 92354 | — |
| Clinical Site 1009 | Los Angeles | California | 90024 | — |
| Clinical Site 1022 | Sacremento | California | 95817 | — |
| Clinical Site 1045 | San Diego | California | 92103 | — |
| Clinical Site 1049 | San Diego | California | 92123 | — |
| Clinical Site 1044 | San Francisco | California | 94115 | — |
| Clinical Site 1011 | Denver | Colorado | 80220 | — |
| Clinical Site 1003 | New Haven | Connecticut | 06520 | — |
| Clinical Site 1036 | Gainesville | Florida | 32610 | — |
| Clinical Site 1013 | Miami | Florida | 33136 | — |
| Clinical Site 1038 | Orlando | Florida | 32804 | — |
| Clinical Site 1006 | Tampa | Florida | 33606 | — |
| Clinical Site 1055 | Atlanta | Georgia | 30309 | — |
| Clinical Site 1053 | Chicago | Illinois | 60612 | — |
| Clinical Site 1056 | Peoria | Illinois | 61603 | — |
| Clinical Site 1026 | New Orleans | Louisiana | 70112 | — |
| Clinical Site 1052 | Portland | Maine | 04102 | — |
| Clinical Site 1014 | Boston | Massachusetts | 02111 | — |
| Clinical Site 1018 | Detroit | Michigan | 48236 | — |
| Clinical Site 1048 | Hackensack | New Jersey | 07601 | — |
| Clinical Site 1037 | Livingston | New Jersey | 07039 | — |
| Clinical Site 1033 | New Brunswick | New Jersey | 08901 | — |
| Clinical Site 1060 | Albany | New York | 12208 | — |
| Clinical Site 1042 | Buffalo | New York | 14203 | — |
| Clinical Site 1040 | East Setauket | New York | 11733 | — |
| Clinical Site 1050 | New York | New York | 10016 | — |
| Clinical Site 1019 | New York | New York | 10029 | — |
| Clinical Site 1025 | New York | New York | 10065 | — |
| Clinical Site 1035 | The Bronx | New York | 10467 | — |
| Clinical Site 1010 | Valhalla | New York | 10595 | — |
| Clinical Site 1051 | Chapel Hill | North Carolina | 27599 | — |
| Clinical Site 1032 | Durham | North Carolina | 27710 | — |
| Clinical Site 1058 | Greenville | North Carolina | 27834 | — |
| Clinical Site 1005 | Cleveland | Ohio | 44106 | — |
| Clinical Site 1054 | Harrisburg | Pennsylvania | 17105-8700 | — |
| Clinical Site 1023 | Philadelphia | Pennsylvania | 19102 | — |
| Clinical Site 1021 | Providence | Rhode Island | 02903 | — |
| Clinical Site 1012 | Charleston | South Carolina | 29425 | — |
| Clinical Site 1047 | Nashville | Tennessee | 37232 | — |
| Clinical Site 1029 | Houston | Texas | 77030 | — |
| Clinical Site 1061 | San Antonio | Texas | 78215-2035 | — |
| Clinical Site 1039 | San Antonio | Texas | 78229 | — |
| Clinical Site 1027 | Richmond | Virginia | 23298 | — |
| Clinical Site 1046 | Madison | Wisconsin | 53792 | — |
| Clinical Site 1008 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01187953, 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 May 18, 2016 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01187953 live on ClinicalTrials.gov.