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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02963103
• Other study ID #: PRG-KT-10-01
• Status: Terminated
• Phase: Phase 4
• First received: October 6, 2016
• Last updated: November 22, 2016
• Start date: May 2010
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Tacrolimus
Oral

Locations

Country	Name	City	State
Korea, Republic of	KR00001	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in GFR	GFR: glomerular filtration rate	Baseline and Week 24	No
Secondary	Change from baseline in total cholesterol		Baseline and Week 24	Yes
Secondary	Change from baseline in Triglycerides		Baseline and Week 24	Yes
Secondary	Change from baseline in LDL	LDL: low density lipoprotein cholesterol	Baseline and Week 24	Yes
Secondary	Change from baseline in HDL	HDL: high density lipoprotein cholesterol	Baseline and Week 24	Yes
Secondary	Change from baseline in the number of antihyperlipidemic drugs		Baseline and Week 24	Yes
Secondary	Change from baseline in blood pressure		Baseline and Week 24	Yes
Secondary	Change from baseline in the number of antihypertensive drugs		Baseline and Week 24	Yes
Secondary	Change from baseline in number of participants who have had hirsutism	Investigator's judgment	Baseline and Week 24	Yes
Secondary	Change from baseline in number of participants who have had gingival hypertrophy	Investigator's judgment	Baseline and Week 24	Yes
Secondary	Overall incidence rate of adverse events		up to Week 24	No
Secondary	Proportion of participants with patient survival		up to Week 24	No
Secondary	Proportion of participants with organ survival		up to Week 24	No
Secondary	Acute rejection rate confirmed by biopsy		up to Week 24	No
Secondary	Ratio of mean dose of cyclosporine to tacrolimus		up to Week 24	No