Status:
COMPLETED
Telmisartan Versus Losartan in Kidney Transplantation
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Renal Transplant
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
In renal transplant recipients, residual renal insufficiency combined to the effects of immunosuppressive therapy with steroids or calcineurin inhibitors may reduce insulin activity and may contribute...
Detailed Description
BACKGROUND In renal transplant recipients, residual renal insufficiency combined to the effects of immunosuppressive therapy with steroids or calcineurin inhibitors may reduce insulin activity and may...
Eligibility Criteria
Inclusion
- Informed consent;
- Age \> 18 years;
- Single renal transplant or dual marginal \> 6 months duration;
- Blood pressure \>130/85 mmHg or need for anti-hypertensive therapy;
- Stable renal function (changes in serum creatinine \< 30%) and no acute rejection episodes in the last six months;
- Stable (for at least six months) dual or triple immunosuppressive therapy including corticosteroids or calcineurin inhibitors;
- Legal capacity.
Exclusion
- Vascular disease of the kidney;
- Heart failure: NYHA classification class III-IV on ACE or AII inhibitor therapy;
- Cerebral haemorrhage, stroke or TIA within three months prior to study enrolment;
- Myocardial infarction within three months prior to study enrolment;
- Unstable angina pectoris;
- Severe hepatic disease;
- Pregnancy or women of child-bearing potential without following a scientifically accepted form of contraception;
- Overt diabetes or concomitant treatment with oral antidiabetic agents and/or insulin;
- Specific clinical indication (other than arterial hypertension) to be treated with ACE inhibitors or AII receptor antagonists;
- Specific contraindications or history of hypersensitivity to the study drugs, glitazones, ACE inhibitors or AII receptor antagonists;
- Participation to other clinical trials over the last three months;
- Legal incapacity;
- Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01224860
Start Date
January 1 2009
End Date
January 1 2014
Last Update
February 25 2014
Active Locations (1)
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1
Mario negri Institute - Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020