Is T-lymphocyte Calcineurin Phosphatase Up-regulated by Treatment With Tacrolimus?

NCT00999362 | Completed DMC

• 1 other identifier: TAC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether calcineurin phosphatase in the T-lymphocytes is up-regulated after long-term treatment with tacrolimus, a calcineurin inhibitor.

Conditions

Kidney Transplantation

Keywords

calcineurin activity; real-time PCR; Gene expression of calcineurin; T-lymphocytes; interferon-gamma; Pharmacodynamics; Pharmacokinetics; tacrolimus; western blot; Hoechst

Outcome Measures

Primary Outcomes (4)

• Gene expression of calcineurin in T-lymphocytes

  Trough level and 2 hours postdose

• Calcineurin activity measured in whole blood and in isolated T-lymphocytes

  Trough level and 2 hours postdose

• Amount of Calcineurin in T-lymphocytes

  Trough level and 2 hours postdose

• Interferon-gamma production

  Trough level and 2 hours postdose

Secondary Outcomes (2)

• Tacrolimus concentration in whole blood

  Trough level and 2 hours postdose

• Number of T-lymphocytes

  Trough level and 2 hours postdose

Study Arms (2)

Early kidney-transplant recipients

Patients receiving a kidney transplantation at Aarhus University Hospital, Skejby and receiving tacrolimus as part of their immunosuppressive regime.

stable kidney transplant recipients

Tacrolimus treated kidney-transplant recipients from the out-door clinic at Aarhus University Hospital, Skejby and more than two years after transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kidney transplant recipients from Department of Nephrology, Aarhus University Hospital, Skejby, Denmark

You may qualify if:

• Group 1 (early kidney-transplant recipients)
• Age over 18 years
• consecutively kidney-transplant recipients at Department of Nephrology, Aarhus University Hospital, Skejby, Denmark
• receiving tacrolimus as part of their immunosuppressive treatment
• receipt of graft from either deceased or living-related donor
• written consent to participate
• Group 2 (stable kidney-transplant recipients)
• Age over 18 years
• Stable renal allograft function defined as S-creatinine \<200 µmol/l
• receipt of graft from either deceased or living-related donor
• written consent to participate

You may not qualify if:

• Group 1 (early kidney-transplant recipients)
• patients suspected of non-compliance
• patients receiving medications known to interact with tacrolimus pharmacokinetics
• patients who on day 8 after transplantation have not reached a trough level for blood tacrolimus concentration above 8 µg/l.
• Group 2 (stable kidney-transplant recipients)
• patients suspected of non-compliance
• patients receiving medications known to interact with tacrolimus pharmacokinetics

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Society of Nephrology: collaborator
• The Danish Kidney Association: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (1)

Department of Nephrology, Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Study Officials

• Dorthe M Mortensen, MD

  Department of nephrology, Aarhus University Hospital,Skejby, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: October 21, 2009
• Study Start: October 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 21, 2009

Record last verified: 2009-10

Locations

DK (1)