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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 May 2015
• Main ID: NCT02432053
• Date of registration: 28/04/2015
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Inc
• Public title: A Study to Demonstrate Safety and Efficacy of Advagraf in Patients Undergoing Kidney or Liver Transplantation in India
• Scientific title: 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
• Date of first enrolment: March 2012
• Target sample size: 92
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02432053
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Medical Director
• Affiliation: Astellas Pharma Inc

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Transplantation

Liver Transplantation

Intervention(s)

Drug: Advagraf

Primary Outcome(s)

Renal function (evaluated by level of Serum Creatinine) [Time Frame: from Day 0 to Week 12]

Incidence of New-Onset Diabetes Mellitus After Transplant (NODAT) [Time Frame: 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]

Incidence of infection [Time Frame: from Day 0 to Week 12]

Lipid profile [Time Frame: 0, 4, and 12-week]

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]

Secondary Outcome(s)

Severity of biopsy confirmed acute rejections [Time Frame: from Day 0 to Week 12]

Time to first biopsy confirmed acute rejection episode [Time Frame: from Day 0 to Week 12]

Incidence of corticosteroid resistant rejection [Time Frame: from Day 0 to Week 12]

Incidence of corticosteroid sensitive rejection [Time Frame: from Day 0 to Week 12]

Overall frequency of acute rejection episodes [Time Frame: from Day 0 to Week 12]

Death [Time Frame: Week 12]

Graft loss [Time Frame: Week 12]

Incidence of use of anti-lymphocyte antibodies [Time Frame: from Day 0 to Week 12]

Secondary ID(s)

AS/111/10

F506-CL-0894

Source(s) of Monetary Support

Please refer to primary and secondary sponsors