Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT01224860
Eligibility Criteria:
Inclusion Criteria:
* 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 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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01224860
Study Brief:
Protocol Section:
NCT01224860