A Study to Demonstrate Safety and Efficacy of Advagraf in Patients Undergoing Kidney or Liver Transplantation in India

April 28, 2015 updated by: Astellas Pharma Inc

An Open Label, Multi-centre, Prospective Study to Demonstrate Safety and Efficacy of Once Daily Advagraf in Patients Undergoing Kidney or Liver Transplantation in India

The objective of the study is to demonstrate safety and efficacy of once-daily Advagraf in adult population undergoing kidney or liver transplantation in India.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a phase IV, multi-centre, open label prospective study of once daily Advagraf in 200 patients undergoing kidney or liver transplantation in India. Adult patients undergoing kidney or liver transplantation and meeting all other eligibility criteria will be enrolled in the study. Enrolled patients will be administered once daily dose of Advagraf for 12 weeks. During these 12 weeks a total of 9 regular visits will be undertaken.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Andhra Pradesh, India
      • Bangalore, India
      • Chennai, India
      • Mumbai, India
      • New Delhi, India
      • Tamil Nadu, India
      • Uttar Pradesh, India

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (common to kidney and liver transplant patients):

  • Male or female patients between 18 to 65 years of age, undergoing liver or kidney transplantation
  • Female patients of child bearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study. Tacrolimus may reduce the clearance of steroid based contraceptives leading to increased hormone exposure; particular care should be exercised when deciding upon contraceptive measures.
  • Patients should be capable of understanding the purpose and risks of the study, and should provide written informed consent to participate in the study.

Inclusion Criteria (specifically for kidney transplant patients):

  • Patients with end stage kidney disease and who are a suitable candidate for primary kidney transplantation.
  • Patients scheduled to receive a kidney transplant from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type.

Inclusion Criteria (specifically for liver transplant patients):

  • Patients with end stage liver disease and who are a suitable candidate for primary liver transplantation.
  • Patients scheduled to receive a liver transplant from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type.

Exclusion Criteria (common to kidney and liver transplant patients):

  • Previously received or are scheduled to receive an organ transplant other than kidney or liver
  • Undergoing re-transplant from either a cadaveric or living donor
  • Contraindication to the use of tacrolimus or corticosteroids.
  • Malignancy or history of malignancy within the last 5 years, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
  • Systemic infection requiring treatment.
  • Transplantation of kidney or liver from non-heart beating donor.
  • Severe diarrhea, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
  • Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the patient.
  • Simultaneously participating in another investigational drug study or has participated in such study within 28 days prior to entry in this study.
  • Receiving any non-registered medication or has received any non-registered medication within 28 days prior to entry in this study.
  • Pregnant women or breast-feeding mother.
  • Patients or respective donors known to be positive for human immunodeficiency virus (HIV).
  • Unlikely to comply with the visits scheduled in the protocol.

Exclusion criteria (Specifically for kidney transplant patients)

  • Cold ischemia time of the donor kidney > 30 hours.
  • High immunological risk, defined as a positive cross match or PRA grade 50% in the previous 6 months.
  • Liver cirrhosis.
  • Significant liver disease, defined as having either elevated serum glutamic pyruvic transaminase / alanine aminotransferase(SGPT / ALT) (at least 2.5 times the upper value of the normal range at the investigational site) or elevated serum glutamic oxaloacetic transaminase/ aspartate transaminase (SGOT/AST) (at least 2.5 times the upper value of the normal range at the investigational site) or elevated total bilirubin levels (at least 2.5 times the upper value of the normal range at the investigational site) or all of them during the 28 days prior to entry into the study.
  • Patients or respective donors known to be positive for hepatitis B virus (HBV) or hepatitis C virus (HCV).

Exclusion Criteria (specifically for liver transplant patients):

  • Transplanted for hepatocellular carcinoma with a single nodule greater than 5.0 cm in diameter or more than 3 nodules or metastases or vascular tumoral invasion.
  • Serum creatinine 2mg/dL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Transplantation
Advagraf
Drug: Advagraf
Other Names:
  • FK506
  • Modified release tacrolimus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Renal function (evaluated by level of Serum Creatinine)
Time Frame: from Day 0 to Week 12
from Day 0 to Week 12
Lipid profile
Time Frame: 0, 4, and 12-week
0, 4, and 12-week
Incidence of New-Onset Diabetes Mellitus After Transplant (NODAT)
Time Frame: from Day 0 to Week 12
NODAT is defined as a composite endpoint consisting of first occurrence of one of 4 parameters: (1) Two fasting plasma glucose (FPG) levels > 126 mg/dL which are > 30 days apart. (2) Oral hypoglycemic agent use for > 30 consecutive days. (3) Insulin therapy for > 30 consecutive days and (4) HbA1c > 6.5%
from Day 0 to Week 12
Incidence of infection
Time Frame: from Day 0 to Week 12
from Day 0 to Week 12
For kidney transplant patients: Event rate of patients with biopsy-confirmed acute rejections (BCAR) ≥ Grade I according to -The Banff 2007 working classification of renal allograft pathology within the first 12 weeks following kidney transplantation
Time Frame: from Day 0 to Week 12
The biopsy shall be performed prior to the initiation of any anti-rejection therapy and as soon as possible after the onset of clinical / laboratory signs indicative of possible rejection
from Day 0 to Week 12
For liver transplant patients: Event rate of patients with biopsy-confirmed acute rejections (BCAR) with Rejection Activity Index of ≥ 4, within the first 12 weeks following liver transplantation
Time Frame: from Day 0 to Week 12
The biopsy shall be performed prior to the initiation of any anti-rejection therapy and as soon as possible after the onset of clinical / laboratory signs indicative of possible rejection. Biopsy-confirmed acute rejections (BCAR) with Rejection Activity Index was defined according to The 1997 Banff schema for grading liver allograft rejection
from Day 0 to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to first biopsy confirmed acute rejection episode
Time Frame: from Day 0 to Week 12
from Day 0 to Week 12
Overall frequency of acute rejection episodes
Time Frame: from Day 0 to Week 12
from Day 0 to Week 12
Severity of biopsy confirmed acute rejections
Time Frame: from Day 0 to Week 12
from Day 0 to Week 12
Incidence of corticosteroid resistant rejection
Time Frame: from Day 0 to Week 12
from Day 0 to Week 12
Incidence of corticosteroid sensitive rejection
Time Frame: from Day 0 to Week 12
from Day 0 to Week 12
Incidence of use of anti-lymphocyte antibodies
Time Frame: from Day 0 to Week 12
from Day 0 to Week 12
Graft loss
Time Frame: Week 12
Week 12
Death
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • F506-CL-0894
  • AS/111/10 (Other Identifier: Astellas Pharma India)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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