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

NCT02963103 | Terminated Phase 4

• 1 other identifier: PRG-KT-10-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplantation

Keywords

Tacrolimus; Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in GFR

  GFR: glomerular filtration rate

  Baseline and Week 24

Secondary Outcomes (14)

• Change from baseline in total cholesterol

  Baseline and Week 24

• Change from baseline in Triglycerides

  Baseline and Week 24

• Change from baseline in LDL

  Baseline and Week 24

• Change from baseline in HDL

  Baseline and Week 24

• Change from baseline in the number of antihyperlipidemic drugs

  Baseline and Week 24

Study Arms (1)

Tacrolimus group

EXPERIMENTAL

oral

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

Oral

Also known as: Prograf (R)

Tacrolimus group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Korea, Inc.: lead

Study Sites (1)

KR00001

Seoul, Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Korea, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: November 15, 2016
• Study Start: May 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: November 23, 2016

Record last verified: 2016-11

Locations

KR (1)