NCT00187915

Brief Summary

This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

October 20, 2011

Status Verified

October 1, 2011

Enrollment Period

1.3 years

First QC Date

September 14, 2005

Last Update Submit

October 19, 2011

Conditions

Transplant, Kidney

Keywords

Renal transplantCellceptTherapeutic drug levelMycophenolate mofetil (MMF)Mycophenolate Acid (MPA)Oral BioavailabilityImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Number of subjects with an average AUC between 30-60 ng x hr/mL

    7 months

Secondary Outcomes (3)

  • Rate of acute rejection of transplanted kidney

    7 months

  • Number of MPA related toxicities

    7 months

  • Number of dose changes required to obtain MPA AUC target in the first month

    7 months

Study Arms (2)

CellCept + Prograf

OTHER

Standard of Care Regime

Drug: Mycophenolate mofetil + Tacrolimus

CellCept + Neoral

OTHER

Standard of Care Regime

Drug: Mycophenolate mofetil + Cyclosporin

Interventions

Mycophenolate mofetil + TacrolimusDRUG

Target MPA exposure to 30-60 mg/L/h during first month post-transplant

Also known as: MMF, CellCept, Ro 70-0003, Prograf
CellCept + Prograf
Mycophenolate mofetil + CyclosporinDRUG

Target MPA exposure to 30-60 mg/L/h during first month post-transplant

Also known as: MMF, CellCept, RO 70-0003, Neoral
CellCept + Neoral

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary or secondary cadaveric or living donor kidney recipients
  • On Cellcept

You may not qualify if:

  • Multi organ recipients
  • Documented non-compliance
  • Not on a calcineurin inhibitor
  • GFR \<25 ml/min by Cockcroft Gault equation
  • Serum albumin \<2.5 mg/dl
  • Pregnant
  • Active serious digestive disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (18)

  • Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. European Mycophenolate Mofetil Cooperative Study Group. Lancet. 1995 May 27;345(8961):1321-5.

    PMID: 7752752BACKGROUND

  • Sollinger HW. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation. 1995 Aug 15;60(3):225-32. doi: 10.1097/00007890-199508000-00003.

    PMID: 7645033BACKGROUND

  • A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. Transplantation. 1996 Apr 15;61(7):1029-37.

    PMID: 8623181BACKGROUND

  • Meier-Kriesche HU, Steffen BJ, Hochberg AM, Gordon RD, Liebman MN, Morris JA, Kaplan B. Long-term use of mycophenolate mofetil is associated with a reduction in the incidence and risk of late rejection. Am J Transplant. 2003 Jan;3(1):68-73. doi: 10.1034/j.1600-6143.2003.30112.x.

    PMID: 12492713BACKGROUND

  • Meier-Kriesche HU, Steffen BJ, Hochberg AM, Gordon RD, Liebman MN, Morris JA, Kaplan B. Mycophenolate mofetil versus azathioprine therapy is associated with a significant protection against long-term renal allograft function deterioration. Transplantation. 2003 Apr 27;75(8):1341-6. doi: 10.1097/01.TP.0000062833.14843.4B.

    PMID: 12717227BACKGROUND

  • Hale MD, Nicholls AJ, Bullingham RE, Hene R, Hoitsma A, Squifflet JP, Weimar W, Vanrenterghem Y, Van de Woude FJ, Verpooten GA. The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther. 1998 Dec;64(6):672-83. doi: 10.1016/S0009-9236(98)90058-3.

    PMID: 9871432BACKGROUND

  • van Gelder T, Hilbrands LB, Vanrenterghem Y, Weimar W, de Fijter JW, Squifflet JP, Hene RJ, Verpooten GA, Navarro MT, Hale MD, Nicholls AJ. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999 Jul 27;68(2):261-6. doi: 10.1097/00007890-199907270-00018.

    PMID: 10440399BACKGROUND

  • van Gelder T, Shaw LM. The rationale for and limitations of therapeutic drug monitoring for mycophenolate mofetil in transplantation. Transplantation. 2005 Oct 15;80(2 Suppl):S244-53. doi: 10.1097/01.tp.0000186380.61251.fc.

    PMID: 16251857BACKGROUND

  • Shaw LM, Mick R, Nowak I, Korecka M, Brayman KL. Pharmacokinetics of mycophenolic acid in renal transplant patients with delayed graft function. J Clin Pharmacol. 1998 Mar;38(3):268-75. doi: 10.1002/j.1552-4604.1998.tb04424.x.

    PMID: 9549665BACKGROUND

  • van Gelder T, Klupp J, Barten MJ, Christians U, Morris RE. Comparison of the effects of tacrolimus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit. 2001 Apr;23(2):119-28. doi: 10.1097/00007691-200104000-00005.

    PMID: 11294511BACKGROUND

  • Srinivas TR, Meier-Kriesche HU, Kaplan B. Pharmacokinetic principles of immunosuppressive drugs. Am J Transplant. 2005 Feb;5(2):207-17. doi: 10.1111/j.1600-6143.2005.00748.x.

    PMID: 15643980BACKGROUND

  • Yamani MH, Starling RC, Goormastic M, Van Lente F, Smedira N, McCarthy P, Young JB. The impact of routine mycophenolate mofetil drug monitoring on the treatment of cardiac allograft rejection. Transplantation. 2000 Jun 15;69(11):2326-30. doi: 10.1097/00007890-200006150-00018.

    PMID: 10868634BACKGROUND

  • Shaw LM, Pawinski T, Korecka M, Nawrocki A. Monitoring of mycophenolic acid in clinical transplantation. Ther Drug Monit. 2002 Feb;24(1):68-73. doi: 10.1097/00007691-200202000-00012. No abstract available.

    PMID: 11805725BACKGROUND

  • Mourad M, Wallemacq P, Konig J, de Frahan EH, Eddour DC, De Meyer M, Malaise J, Squifflet JP. Therapeutic monitoring of mycophenolate mofetil in organ transplant recipients: is it necessary? Clin Pharmacokinet. 2002;41(5):319-27. doi: 10.2165/00003088-200241050-00001.

    PMID: 12036390BACKGROUND

  • Cattaneo D, Perico N, Gaspari F, Gotti E, Remuzzi G. Glucocorticoids interfere with mycophenolate mofetil bioavailability in kidney transplantation. Kidney Int. 2002 Sep;62(3):1060-7. doi: 10.1046/j.1523-1755.2002.00531.x.

    PMID: 12164891BACKGROUND

  • Shaw LM, Korecka M, Venkataramanan R, Goldberg L, Bloom R, Brayman KL. Mycophenolic acid pharmacodynamics and pharmacokinetics provide a basis for rational monitoring strategies. Am J Transplant. 2003 May;3(5):534-42. doi: 10.1034/j.1600-6143.2003.00079.x. No abstract available.

    PMID: 12752309BACKGROUND

  • Cattaneo D, Gaspari F, Ferrari S, Stucchi N, Del Priore L, Perico N, Gotti E, Remuzzi G. Pharmacokinetics help optimizing mycophenolate mofetil dosing in kidney transplant patients. Clin Transplant. 2001 Dec;15(6):402-9. doi: 10.1034/j.1399-0012.2001.150607.x.

    PMID: 11737117BACKGROUND

  • Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 2002 Oct 27;74(8):1070-6. doi: 10.1097/00007890-200210270-00002.

    PMID: 12438948BACKGROUND

MeSH Terms

Interventions

Mycophenolic AcidTacrolimusCyclosporine

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsMacrolidesLactonesCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Herwig-Ulf Meier-Kriesche, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

July 1, 2003

Primary Completion

November 1, 2004

Study Completion

December 1, 2004

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations

US(1)