Effect of the Inhibition of the Mammalian Target of Rapamycin on Metabolism and Exercise

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an exploratory study based on the hypothesis that kidney transplant patients treated with an immunosuppressive therapy based on an inhibitor of the mammalian target of rapamycin (m-TOR) may increase resistance to physical exercise, which would result in an improvement in the quality of life of these patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Josep M Cruzado
• Treatments: Calcineurin Inhibitors; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

1. Renal transplant patient's aged between 18 and 60 years old.

2. Heart rate in radial pulse and seated between 50 and 100 bpm.

3. Systolic blood pressure between 100 and 140 and diastolic between 50 to 90.

4. Absence of any clinical physical, psychological or psychiatric condition that would prevent from the protocol described follow-up.

5. Estimated glomerular filtration rate greater than 40 ml / min.

6. Proteinuria < 0.5 g / d.

7. Renal transplantation at least 6 months ago.

8. Immunosuppressant based on calcineurin inhibitors.

9. Hemoglobin > 11 g / dl.

10. Body mass index (BMI) < 35 kg/m2.

11. Indication for conversion to everolimus and granting of written informed consent.

Exclusion Criteria:

1. Diabetes mellitus

2. Treatment with erythropoiesis stimulating drugs

3. Treatment with β blockers drugs

4. Participation in any clinical trial in the last 30 days prior to the inclusion.

5. Any other physical illness, psychological or psychiatric condition that could difficult the follow-up of the patient.