Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation

NCT01467011 | Completed FDA Drug

• 1 other identifier: Pro00004722
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to gather information regarding the use of Myfortic, Prograf, and corticosteroids in new liver transplant recipients. These three medicines help to prevent the body from rejecting the transplanted liver. The information the investigators are obtaining is data relating to the process of Myfortic absorption by the body, its distribution in the body, the breakdown of Myfortic in the body, and its elimination from the body. This absorption, distribution, breakdown, and elimination is called pharmacokinetics.

Conditions

End Stage Liver Disease

Keywords

Myfortic; Mycophenolic acid; Prograf; Tacrolimus; Liver transplantation

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic parameters

  Pharmacokinetic time points will be obtained at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, and 12 hours post dose. The exposure (area under the concentration-time curve, AUC μg·h/mL, Cmax ng/mL, and Tmax, hours) of MPA and MPAG will be calculated using non-compartmental analysis.

  Twelve hour pharmacokinetics at one week, one month, and six months post transplant

Secondary Outcomes (1)

• Safety and tolerability

  1 week, 1 month, 6 months

Study Arms (1)

Cases

de novo liver transplant recipients receiving Enteric-coated Mycophenolate Sodium

Drug: Enteric-coated Mycophenolate Sodium

Interventions

Enteric-coated Mycophenolate Sodium DRUG

1440mg/day for 6 months posttransplant

Also known as: mycophenolic acid

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with end stage liver disease who are receiving a liver transplant at The Methodist Hospital in Houston, Texas and who satify the inclusion/exclusion criteria will be considered for the study.

You may qualify if:

• Adults \> or equal to age 18 years
• Planned to receive tacrolimus and corticosteroid therapy posttransplant
• Serum creatinine at transplant \< or equal to 2.5mg/dL
• UCSF tumor staging \< 8cm total
• Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the baseline visit and are required to practice a reliable method of contraception for the duration of the study and for no fewer than 6 weeks after completing the study.
• Signed informed consent form prior to any research assessment

You may not qualify if:

• Induction therapy
• Requiring dialysis at the time of transplant
• Organ transplant other than liver
• Pregnant or nursing females
• Women of childbearing potential not practicing reliable methods of contraception. Reliable methods for contraception include surgical sterilization (hysterectomy, bilateral tubal ligation), double-barrier method (such as condom and diaphragm). To be considered as post-menopausal and not of childbearing potential, female subjects must have experienced 12 consecutive months of amenorrhea.
• Require any medications that interfere with metabolism of Myfortic (other than corticosteroids)
• Have a known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or any of its excipients
• Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug

Sponsors & Collaborators

• R. Mark Ghobrial, MD: lead
• Novartis: collaborator

Study Sites (1)

The Methodist Hospital System

Houston, Texas, 77030, United States

Location

Related Publications (7)

• Plank LD, Metzger DJ, McCall JL, Barclay KL, Gane EJ, Streat SJ, Munn SR, Hill GL. Sequential changes in the metabolic response to orthotopic liver transplantation during the first year after surgery. Ann Surg. 2001 Aug;234(2):245-55. doi: 10.1097/00000658-200108000-00015.

  PMID: 11505071 BACKGROUND

• de Carvalho L, Parise ER, Samuel D. Factors associated with nutritional status in liver transplant patients who survived the first year after transplantation. J Gastroenterol Hepatol. 2010 Feb;25(2):391-6. doi: 10.1111/j.1440-1746.2009.06033.x. Epub 2009 Nov 19.

  PMID: 19929929 BACKGROUND

• Pisupati J, Jain A, Burckart G, Hamad I, Zuckerman S, Fung J, Venkataramanan R. Intraindividual and interindividual variations in the pharmacokinetics of mycophenolic acid in liver transplant patients. J Clin Pharmacol. 2005 Jan;45(1):34-41. doi: 10.1177/0091270004270145.

  PMID: 15601803 BACKGROUND

• Jain A, Venkataramanan R, Hamad IS, Zuckerman S, Zhang S, Lever J, Warty VS, Fung JJ. Pharmacokinetics of mycophenolic acid after mycophenolate mofetil administration in liver transplant patients treated with tacrolimus. J Clin Pharmacol. 2001 Mar;41(3):268-76. doi: 10.1177/00912700122010087.

  PMID: 11269567 BACKGROUND

• Arns W, Breuer S, Choudhury S, Taccard G, Lee J, Binder V, Roettele J, Schmouder R. Enteric-coated mycophenolate sodium delivers bioequivalent MPA exposure compared with mycophenolate mofetil. Clin Transplant. 2005 Apr;19(2):199-206. doi: 10.1111/j.1399-0012.2004.00318.x.

  PMID: 15740555 BACKGROUND

• Perry TW, Christians U, Trotter JF, Bendrick-Peart J. Pharmacokinetics of enteric-coated mycophenolate sodium in stable liver transplant recipients. Clin Transplant. 2007 May-Jun;21(3):413-6. doi: 10.1111/j.1399-0012.2007.00662.x.

  PMID: 17488394 BACKGROUND

• Kaczmarek I, Bigdeli AK, Vogeser M, Mueller T, Beiras-Fernandez A, Kaczmarek P, Schmoeckel M, Meiser B, Reichart B, Ueberfuhr P. Defining algorithms for efficient therapeutic drug monitoring of mycophenolate mofetil in heart transplant recipients. Ther Drug Monit. 2008 Aug;30(4):419-27. doi: 10.1097/FTD.0b013e31817d7064.

  PMID: 18641552 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum will be retained and frozen for MPA levels

MeSH Terms

Conditions

End Stage Liver Disease

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• R M Ghobrial, MD, PhD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 8, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 16, 2018

Record last verified: 2018-05

Locations

US (1)