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Telmisartan Versus Losartan in Kidney Transplantation

NCT01224860 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-02-25

No results posted yet for this study

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 to several of the abnormalities associated with the metabolic syndrome, such as hypertension, glucose intolerance and hyperlipidemia. In turn, insulin resistance, hypertension, hyperglycemia and dyslipidemia may importantly contribute to the excess cardiovascular risk of renal transplant patients (an excess comparable to that of diabetes subjects with over diabetic nephropathy)and may also accelerate progressive renal function deterioration and promote graft loss. Thus, amelioration of the insulin activity and of the related metabolic syndrome is a key component of treatments aimed to improve patient and graft survival in renal transplant recipients. Recently, drugs such as peroxisome proliferators-activated receptor-gamma activators, that ameliorate insulin sensitivity and metabolic syndrome, have become available.These agents, however, can provoke fluid retention, weight gain, edema and, in some cases, heart failure.

Recent studies showed that telmisartan, an angiotensin II type 1 receptor antagonist, in addition to block the angiotensin II type 1 - a key surface receptor involved in the regulation of blood pressure - may also activate peroxisome proliferators-activated receptor-gamma activators, thus improving some of the features of the metabolic syndrome. Thus telmisartan may substantially reduce the overall cardiovascular and renal risk of renal transplant recipients by ameliorating some of the modifiable components of the metabolic syndrome. On the other hand, telmisartan is devoid of the adverse effects of peroxisome proliferators-activated receptor-gamma activators such as fluid retention, and has therefore a remarkably better risk/benefit profile. Thus, whether telmisartan in addition to the beneficial effects of a reference angiotensin II type 1 receptor antagonist (such as losartan) may offer adjunctive advantages related to improved insulin sensitivity in renal transplant patients on chronic therapy with steroids and/or calcineurin inhibitors, is worth investigating.

Conditions

  • Renal Transplant

Interventions

DRUG

Telmisartan

One week 40 mg daily, followed by fifteen weeks treatment period with 80 mg daily.

DRUG

Losartan

One week 50 mg daily, followed by fifteen weeks treatment period with 100 mg daily.

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-06-30
Completion
2014-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01224860 on ClinicalTrials.gov