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

NCT02432053 | Completed Phase 4

• 2 other identifiers: F506-CL-0894AS/111/10
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Kidney Transplantation; Liver Transplantation

Keywords

FK506; Advagraf; Tacrolimus; Transplantation

Outcome Measures

Primary Outcomes (6)

• Renal function (evaluated by level of Serum Creatinine)

  from Day 0 to Week 12

• Lipid profile

  0, 4, and 12-week

• Incidence of New-Onset Diabetes Mellitus After Transplant (NODAT)

  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

  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

  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

  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 Outcomes (8)

• Time to first biopsy confirmed acute rejection episode

  from Day 0 to Week 12

• Overall frequency of acute rejection episodes

  from Day 0 to Week 12

• Severity of biopsy confirmed acute rejections

  from Day 0 to Week 12

• Incidence of corticosteroid resistant rejection

  from Day 0 to Week 12

• Incidence of corticosteroid sensitive rejection

  from Day 0 to Week 12

Study Arms (1)

Transplantation

EXPERIMENTAL

Advagraf

Drug: Advagraf

Interventions

Advagraf DRUG

Also known as: Modified release tacrolimus, FK506

Transplantation

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (7)

Unknown Facility

Andhra Pradesh, India

Location

Unknown Facility

Bangalore, India

Location

Unknown Facility

Chennai, India

Location

Unknown Facility

Mumbai, India

Location

Unknown Facility

New Delhi, India

Location

Unknown Facility

Tamil Nadu, India

Location

Unknown Facility

Uttar Pradesh, India

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma 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: April 28, 2015
• First Posted: May 1, 2015
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

IN (7)