Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
This study is currently recruiting participants.
Verified December 2012 by Astellas Pharma Inc
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01332201
First received: April 7, 2011
Last updated: December 3, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery. This is followed by checking of safety and effectiveness for one year.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Transplantation Lung Transplantation Pancreas (Including SPK) Transplantation |
Drug: Advagraf Drug: Prograf |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase II, Open Label, Parallel Group, Multi-center Study to Compare the Pharmacokinetics of Tacrolimus in Adult Subjects Undergoing Primary Allograft Transplantation Receiving an Advagraf® or Prograf® Based Immunosuppressive Regimen, Including a Long-term Follow-up |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- determine steady state systemic exposure (AUC 0-24h) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- determine Cmax (maximum concentration) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ] [ Designated as safety issue: No ]
- determine tmax (time to attain Cmax) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ] [ Designated as safety issue: No ]
- determine C24 (concentration prior to next morning dose) [ Time Frame: Day 1, Day 3, Day 7 and Day 42 ] [ Designated as safety issue: No ]
- describe rejection episodes [ Time Frame: up to 58 weeks ] [ Designated as safety issue: No ]
- describe subject survival [ Time Frame: up to 58 weeks ] [ Designated as safety issue: No ]
- describe graft survival [ Time Frame: up to 58 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Advagraf |
Drug: Advagraf
oral
Other Names:
|
| Active Comparator: Prograf |
Drug: Prograf
oral
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- must receive first oral dose of tacrolimus one day (lung, pancreas or Simultaneous Pancreas Kidney (SPK) recipients) or three days (heart recipients) after transplantation (skin closure)
- negative pregnancy test prior to enrolment (females)
- agree to practice effective birth control during the study
- treated since transplantation with Antithymocyte globulin/ Mycophenolate Mofetil/steroids (ATG/MMF/steroids), gastric motility resumed and renal function adequate (<230 µmol/l (<2.6 ml/dl)) on Day 1
Exclusion Criteria:
- receiving a multi-organ transplant (with the exception of SPK) or previously received an organ transplant (including re-transplantation)
- pulmonary vascular resistance ≥4 Wood units despite medication
- required an emergency ventricular assist device within one week prior to transplantation
- significant renal impairment
- significant liver disease
- malignancies or a history of malignancy within the last 5 years
- significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastrointestinal disorder that may affect the absorption of tacrolimus, or active peptic ulcer
- requires systemic immunosuppressive medication for any other indication than transplantation
- diagnosis of cystic fibrosis
- pregnant or breast-feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332201
Contacts
| Contact: Medical Affairs Europe | + 44 1784 419400 | contactl@nl.astellas.com |
Locations
| Austria | |
| Recruiting | |
| Vienna, Austria | |
| Active, not recruiting | |
| Vienna, Austria | |
| Belgium | |
| Recruiting | |
| Leuven, Belgium | |
| France | |
| Recruiting | |
| Paris, France | |
| Italy | |
| Recruiting | |
| Milan, Italy | |
| Recruiting | |
| Padova, Italy | |
| Taiwan | |
| Recruiting | |
| Taipei, Taiwan | |
| United Kingdom | |
| Not yet recruiting | |
| London, United Kingdom | |
| Recruiting | |
| Manchester, United Kingdom | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Study Chair: | Use Central Contact | Astellas Pharma Europe Ltd. |
More Information
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT01332201 History of Changes |
| Other Study ID Numbers: | PMR-EC-1501, 2010-019859-21 |
| Study First Received: | April 7, 2011 |
| Last Updated: | December 3, 2012 |
| Health Authority: | Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: National Institute of Health Taiwan : Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Astellas Pharma Inc:
|
Advagraf Heart Lung Pancreas |
Transplant Immunosuppression Pharmacokinetics |
Additional relevant MeSH terms:
|
Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013