| Trial ID: | L3224 |
| Source ID: | NCT01002339
|
| Associated Drug: |
Tacrolimus With Rapid Steroid Withdrawal
|
| Title: |
Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation
|
| Acronym: |
01-DMPT
|
| Status: |
TERMINATED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01002339/results
|
| Conditions: |
Diabetes Mellitus, Adult-Onset
|
| Interventions: |
DRUG: Tacrolimus with rapid steroid withdrawal|DRUG: Tacrolimus with steroids minimization|DRUG: CsA with steroid minimization
|
| Outcome Measures: |
Primary: Primary Outcome Measure "New Onset Diabetes After Renal Transplantation" (NODAT), American Diabetes Association criteria (ADA) including an oral glucose tolerance test., 1 year|Patients Treated With Insulin or Oral Antidiabetic Drugs, 1 year|Primary Outcome Measure (Glucose Intolerance), Glycemia \>=140 and \<200 mg/dl, 2 hours after a standard oral glucose tolerance test. Measured values: glucose intolerance at 1 year defined by ADA criteria., 1 year | Secondary: Rejection, Biopsy proven acute rejection. Measured variable: Rate of Biopsy proven acute rejection., 1 year|Renal Function, Estimated Glomerular Filtration Rate (ml/min/1.73 m\^2), 1 year|Proteinuria, 1 year|Blood Pressure, Systolic pressure (mmHg), 1 year|Blood Pressure, Diastolic pressure (mmHg), 1 year|Number of Antihypertensive Drugs Patients Reported Taking., 1 year|Lipidic Profile (Triglycerides), 1 year|Lipidic Profile (Cholesterol), Lipidic Profile (total cholesterol), 1 year|Lipidic Profile (HDL-c), 1 year|Lipidic Profile (LDL-c), 1 year|Percentage of Patients Using Statins, 1 year|Changes of Carotid Intima-media Thickness Over Time, absolute difference between carotid intima-media thickness at study end versus baseline., 1 year|Percentage of Patients Using Acetylsalicylic Acid (ASA), 1 year
|
| Sponsor/Collaborators: |
Sponsor: Armando Torres Ramírez
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
134
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2010-02
|
| Completion Date: |
2015-06
|
| Results First Posted: |
2016-08-03
|
| Last Update Posted: |
2024-10-22
|
| Locations: |
Antonio Osuna, Granada, Andalucía, 18014, Spain|Domingo Hernández, Málaga, Andalucía, 29010, Spain|Carmen Díaz Corte, Oviedo, Asturias, 33006, Spain|Carlos Gómez Alamillo, Santander, Cantabria, 39008, Spain|Juan Manuel Díaz, Barcelona, Cataluña, 08025, Spain|Francisco Moreso, Barcelona, Cataluña, 08035, Spain|Francisco Valdés, La Coruña, Galicia, 15006, Spain|Armando Torres Ramírez, La Laguna, S/C De Tenerife, 38320, Spain|Roberto Gallego, Las Palmas de Gran Canaria, 35010, Spain|Luis Pallardo, Valencia, 46017, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT01002339
|
