Submitted by: Marissa Macaraeg Laureta 2015-10-01 00:00:00 Last Updated by: Marissa Macaraeg Laureta 2015-10-07 10:42:49 Export to PDF

Global Multicentre Kidney Transplant Advagraf Conversion Registry. A non-interventional post-authorisation study (PAS)

PHRR151005-001101

506- MA-1002

Unspecified

Global Multicentre Kidney Transplant Advagraf Conversion Registry. A non-interventional post-authorisation study (PAS)

This is a multicenter long-term (up to five years post-conversion), non-interventional registry in kidney transplant patients who have been converted from tacrolimus BD to Advagraf

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2015-11-03 60 2020-11-03 0000-00-00

Pending

Not stated

Institution Classification Region LTO #
Astellas Pharma Europe Ltd. Private Business Italy
Institution Classification Region LTO #
PAREXEL Clinical Research (Philippines) Ltd. Corp. Private Business NCR
Institution Amount Region
Astellas Pharma Europe Ltd. N/A Italy
Name E-Mail Phone Number Postal Address
Ayereece Bartocillo AyeReece.Bartocillo@parexel.com +632 988 6286 15th Floor, Philam Life Tower 8767 Paseo De Roxas Makati City, Philippines 1226
Name E-Mail Phone Number Postal Address
Martin Hurst BSc, MBBS, FRCP martin.hurst@astellas.com +44 (0)203 379 8334 Astellas Pharma Europe Ltd 2000 Hillswood Drive Chertsey Surrey KT16 0RS
Name Expertise Affiliation
Franklin Britan Guillano, MD Nephrologist Alexian Brothers Health and Wellness Center
Glenda Eleonor P. Pamugas, MD Nephrologist National Kidney and Transplant Institute
Juliet Kaw-Navarro, MD Nephrologist St. Luke's Medical Center - Quezon City
Project Location Institutional Ethics Review Board
Alexian Brothers Health and Wellness Center Philippine General Hospital Research Implementation and Development Office
National Kidney and Transplant Institute National Kidney and Transplant Institute Ethics Review Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Board

kidney transplant patients who are on tacrolimus BD andidentified for conversion to Advagraf.

  • To evaluate changes over time in renal function from Baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus BD formulations to a once daily formulation as Advagraf.

●To review long-term trends in Advagraf dosing, tacrolimus trough and concomitant immunosuppression.
● To evaluate acute rejection both BPAR and clinically treated.
● To evaluate graft survival and patient survival.
● To evaluate emergence of DSA (centre specific – routine sequential sampling).
● To evaluate discontinuation rate of treatment with Advagraf and the reasons associated with discontinuation.
● To evaluate diagnosis of medical condition of interest: any malignant disease, CMV and BK virus, any cardiovascular events (e.g. myocardial infarction, stroke), hypertension, hyperlipidemia and development and progression of DM.

Pending

  • Australia
  • Austria
  • Belgium
  • Canada
  • Czech Republic
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Italy
  • Malaysia
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey
  • United Kingdom
  • Vietnam

Clinical Trial

Unspecified

2015-08-24

None

Inclusion criteria:
 Adult (age > 18 years) kidney transplant patients who are on tacrolimus BD and identified for conversion to Advagraf. Patients will only be approached about participating in the registry after their physician has made the decision to convert them to Advagraf therapy. Patients previously treated with Advagraf and who have stopped for any reason will not be excluded from the registry provided that the
physician has decided to convert.
 Provided informed consent to participate in 506-MA-1002. Written or verbal informed consent, as per national regulations will be obtained. In countries where only verbal informed consent is required, the Investigator should document this in the patient’s medical records.
Exclusion criteria:
 Patients currently taking Advagraf treatment.

Observational

Unspecified

Unspecified

Non-randomized

Open Label

Unspecified

Not Applicable

To investigate the long term outcomes in kidney transplant patients on Advagraf under conditions of routine clinical practice we propose a multicentre registry of kidney transplant recipients identified for conversion from tacrolimus BD to Advagraf.

Phase IV

60

Unspecified

Unspecified

03 Nov 2015

Utilization Utilization Info
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