kidney transplant MedDRA version: 14.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 100000004865
Conditions
Interventions
Trade Name: MICARDIS
Pharmaceutical Form: Tablet
INN or Proposed INN: Telmisartan
Concentration unit: mg milligram(s)
Concentration number: 20-
Trade Name: LORTAAN
Pharmaceutical Form: Tablet
INN or
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the short-term effects of telmisartan and losartan on insulin sensitivity in kidney transplant recipients with stable renal function and concomitant treatment with steroids and/or calcineurin inhibitors.;Secondary Objective: To compare in the above cohort of patients the effects of telmisartan and losartan on lipid profile, glucose tolerance, and renal function;Primary end point(s): Insulin sensitivity (i.e. glucose disposal rate as assessed by an euglycemic hyperinsulinemic clamp);Timepoint(s) of evaluation of this end point: At baseline, at the end of the two treatment periods and at recovery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Systemic - Sitting systolic/diastolic blood pressure; - 24-h blood pressure profile; Metabolic - Morning fasting blood glucose; - Glucose tolerance test; - Glicated hemoglobin; - Morning fasting insulin, HOMA index; - Lipid profile (total cholesterol, triglycerides, HDL, LDL, apolipoprotein A, B); Renal - UAE; - GFR/RPF; - Albumin fractional clearance.;Timepoint(s) of evaluation of this end point: At baseline, at the end of the two treatment periods and at recovery. | — |
Countries
Italy
Contacts
Public ContactLab. att. regolatorie studi clinici
Istituto di Ricerche Farmacologiche Mario Negri
Outcome results
None listed