Clinical trial designed to compare the metabolic effects of Telmisartan compared with Losartan in patients with renal transplantatio

• Conditions: kidney transplant; MedDRA version: 14.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2008-000822-38-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-31
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Informed consent; - Age > 18 years; - Single or dual marginal renal transplant > 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

- 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 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified