The Effects of Conversion From Cyclosporine to Tacrolimus on the Changes of Cardiovascular Risk Profiles and Serum Metabolites in Renal Transplant Recipients

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effects of conversion from cyclosporine to tacrolimus on the changes of cardiovascular risk profiles and serum metabolites in renal transplant recipients.

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

Details

• Lead Sponsor: Kyungpook National University; Kyungpook National University Hospital
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. Patients who received a kidney transplant at least 12 months ago prior to enrollment

2. Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment.

3. Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial

4. Patients who are considered clinically stable by observer's judgment.

5. Patients must understand the purpose and risk of participating the the trial and signed on the written consent.

Exclusion Criteria:

1. Patients who have previously received an organ transplant other than a kidney

2. Patients diagnosed with congestive heart failure within 6 months (EF <35%)

3. Patients with untreated ischemic heart disease

4. Patients whose hemoglobin is in the level of <7.0 g/dL

5. Patients who have a known hypersensitivity to tacrolimus

6. Patients taking potassium sparing diuretics

7. Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted

8. Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer

9. Patients who are pregnant or lactating