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AzTrials

Transplant, KidneyMPANCT00187915

Pilot Trial for Implementation of a MPA PK Monitoring Strategy

A study testing Mycophenolate mofetil + Tacrolimus and Mycophenolate mofetil + Cyclosporin in people with Transplant, Kidney, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Transplant, Kidney
What is being tested?
Mycophenolate mofetil + Tacrolimus and Mycophenolate mofetil + Cyclosporin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Jul 2003to Dec 2004
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida

    Gainesville, Florida, 32610

Other trials in United States

About this study

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.

Read the detailed description

Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid (MPA), the active immunosuppressant.

MMF significantly decreases the episodes of acute rejection in kidney transplant patients; but as with any medication without adequate pharmacokinetic drug monitoring, the issue of under or over immunosuppression arises. For this reason, the biggest challenge lies with establishing a feasible mean of MPA pharmacokinetic monitoring. Thus far no study has shown that measuring MPA trough levels alone correlates with rejection, unlike MPA Area Under the concentration time Curve (AUC), due to the large incidence of inter- and intra-patient variability.

This is the first prospective blinded trial set up to analyze the correlation between individualized MPA AUC and trough levels of kidney transplant patients in hopes of establishing a more efficacious way of monitoring MPA. MPA target trough levels that correspond to AUC greater than 30 mg x h/L could then be utilized as maintenance measurements.

Being tested
Mycophenolate mofetil + Tacrolimus, Mycophenolate mofetil + Cyclosporin
Keywords
Renal transplant, Cellcept, Therapeutic drug level, Mycophenolate mofetil (MMF), Mycophenolate Acid (MPA), Oral Bioavailability, Immunosuppression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mycophenolate mofetil + TacrolimusDrug

    Also called MMF, CellCept, Ro 70-0003, Prograf

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

  • Mycophenolate mofetil + CyclosporinDrug

    Also called MMF, CellCept, RO 70-0003, Neoral

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

Study groups in NCT00187915
Study groupRoleWhat they receive
CellCept + PrografOtherStandard of Care Regime
Receives: Drug: Mycophenolate mofetil + Tacrolimus
CellCept + NeoralOtherStandard of Care Regime
Receives: Drug: Mycophenolate mofetil + Cyclosporin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 7 months

Secondary outcomes (3)

  1. Rate of acute rejection of transplanted kidney

    Measured: 7 months

  2. Number of MPA related toxicities

    Measured: 7 months

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

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startJul 2003
  3. Primary completionNov 2004
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00187915
Sponsor's protocol ID
CEL330
Other IDs
20030499
Acronym
MPA
Status last verified
Oct 2011
First submitted
14 Sep 2005
Last updated
20 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 7752752

  • 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.

    PubMed 7645033

  • 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.

    PubMed 8623181

  • 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.

    PubMed 12492713

  • 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.

    PubMed 12717227

  • 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.

    PubMed 9871432

  • 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.

    PubMed 10440399

  • 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.

    PubMed 16251857

  • 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.

    PubMed 9549665

  • 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.

    PubMed 11294511

  • 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.

    PubMed 15643980

  • 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.

    PubMed 10868634

  • 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.

    PubMed 11805725

  • 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.

    PubMed 12036390

  • 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.

    PubMed 12164891

Questions about this trial

What is this clinical trial studying?

A study testing Mycophenolate mofetil + Tacrolimus and Mycophenolate mofetil + Cyclosporin in people with Transplant, Kidney, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with an average AUC between 30-60 ng x hr/mL (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00187915, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2011.

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