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

NCT02496494 | Unknown Phase 4 DMC

• 1 other identifier: KNUH 2012-09-010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CYCLOSPORINE/TACROLIMUS

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Blood Pressure at 6 months

  3 months, 6 months

• Change from Baseline in Lipid Profile at 6 months

  3 months, 6 months

Secondary Outcomes (4)

• Assessing glucose regulation using blood glucose and hemoglobin A1c

  3 months, 6 months

• Assessing other metabolic cardiovascular risk factors using fibrinogen, tPA, PAI-I, homocysteine, pro-BNP, hs-CRP, uric acid

  24 weeks

• Assessing serum metabolite using ELISA

  3 months, 6 months

• Assessing renal function using blood urea nitrogen and creatinine

  3 months, 6 months

Study Arms (1)

Tacrolimus conversion group

EXPERIMENTAL

Cyclosprine was converted to tacrolimus in kidney transplant recipients.

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

Tacrolimus for maintenance immunosupression in kidney transplant recipients

Also known as: TacroBell

Tacrolimus conversion group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received a kidney transplant at least 12 months ago prior to enrollment
• Patients who have kept in unchanged cyclosporine therapy at least for 6 months prior to enrollment.
• 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
• Patients who are considered clinically stable by observer's judgment.
• Patients must understand the purpose and risk of participating the the trial and signed on the written consent.

You may not qualify if:

• Patients who have previously received an organ transplant other than a kidney
• Patients diagnosed with congestive heart failure within 6 months (EF \<35%)
• Patients with untreated ischemic heart disease
• Patients whose hemoglobin is in the level of \<7.0 g/dL
• Patients who have a known hypersensitivity to tacrolimus
• Patients taking potassium sparing diuretics
• Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted
• Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer
• Patients who are pregnant or lactating

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Chan-Duck Kim

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan-Duck Kim, M.D., PhD

CONTACT

drcdkim@knu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 14, 2015
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 14, 2015

Record last verified: 2015-07

Locations

KR (1)