A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

A Single-center Pilot Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.

Study Overview

• Status: Terminated
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Tacrolimus

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • KR00001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients received a kidney transplant at least 12 months before enrollment.
• Patients whose dosage of previous immunosuppressants has not been changed and remained for at least 4 weeks before enrollment, and blood trough level of cyclosporine is 100 to 200 ng/mL.
• Patients who have the side effects (hypertension, hyperlipidemia, gingival hyperplasia and hypertrichosis/hirsutism) during use of cyclosporine.
• Serum creatinine < 2.3 mg/dl at enrollment
• Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment, and agreed to use effective contraception during the trial.
• Patients considered clinically stable

Exclusion Criteria:

• Patients who have previously received an organ transplant other than a kidney.
• Patients who have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
• 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 have an underlying disease such as focal segmental glomerulosclerosis (FSGS) or type II membranoproliferative glomerulonephritis (Type II MPGN).
• Proteinuria > 2 g/24 hrs.
• Patients who have "Creeping creatinine" (a 20% increase in their creatinine for six months before their enrollment).
• Patients whose Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) is twice higher than the normal range in the center.
• Patients who have liver cirrhosis.
• Patients who are pregnant or breastfeeding.
• Patients who had been HIV-positive.
• Patients who have a known allergy to Prograf® or its ingredients, steroids or adjuvants.
• Patients who have an unstable medical condition that may affect the evaluation of the study's objectives.
• Patients who are receiving prohibited concomitant medications or who received those medications within 28 days of their enrollment.
• Patients who are currently participating in another clinical trial or who received the investigational drug in another trial within 28 days of their enrollment.
• Patients who are at the risk of drug abuse or mental disorders or communicate difficulties.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacrolimus group; oral	Drug: Tacrolimus; Oral; Other Names: Prograf (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in GFR	GFR: glomerular filtration rate	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in total cholesterol		Baseline and Week 24
Change from baseline in Triglycerides		Baseline and Week 24
Change from baseline in LDL	LDL: low density lipoprotein cholesterol	Baseline and Week 24
Change from baseline in HDL	HDL: high density lipoprotein cholesterol	Baseline and Week 24
Change from baseline in the number of antihyperlipidemic drugs		Baseline and Week 24
Change from baseline in blood pressure		Baseline and Week 24
Change from baseline in the number of antihypertensive drugs		Baseline and Week 24
Change from baseline in number of participants who have had hirsutism	Investigator's judgment	Baseline and Week 24
Change from baseline in number of participants who have had gingival hypertrophy	Investigator's judgment	Baseline and Week 24
Overall incidence rate of adverse events		up to Week 24
Proportion of participants with patient survival		up to Week 24
Proportion of participants with organ survival		up to Week 24
Acute rejection rate confirmed by biopsy		up to Week 24
Ratio of mean dose of cyclosporine to tacrolimus		up to Week 24

Collaborators and Investigators

• Sponsor: Astellas Pharma Korea, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Tacrolimus; Kidney transplantation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: PRG-KT-10-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED