| Trial ID: | L4544 |
| Source ID: | NCT02895113
|
| Associated Drug: |
Aspirin
|
| Title: |
Aspirin and Renal Disease Progression in Patients With Type 2 Diabetes
|
| Acronym: |
LEDA
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes
|
| Interventions: |
DRUG: Aspirin|OTHER: Placebo
|
| Outcome Measures: |
Primary: Changes in renal function in diabetic patients treated with aspirin, The aim of our study is to evaluate the decline in renal function in diabetic patients treated with low-dose aspirin (100 mg/day) vs. untreated diabetic patients. In particular, we will evaluate: * The absolute change in eGFR, calculated as the difference between eGFR at 12 months - baseline eGFR; * The rapid decline in renal function, defined as a reduction of eGFR ≥5 ml/min at 1 years. * The change of renal function class (from G1 to G2, from G2 to G3a and so on) at 6 and 12 months., 1 year | Secondary: Relationship between changes of Thromboxane B2 excretion and renal function in diabetic patients treated with aspirin, As secondary endpoint, we will evaluate changes in the urinary excretion TxB2 both baseline and at one year. Changing levels of urinary TxB2 will then be related to renal function., 1 year
|
| Sponsor/Collaborators: |
Sponsor: University of Roma La Sapienza
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
418
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-01
|
| Completion Date: |
2018-09
|
| Results First Posted: |
|
| Last Update Posted: |
2016-09-09
|
| Locations: |
Internal and Medical Specialities Department - Policlinico Umberto I, Rome, 00161, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT02895113
|
