Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate how quickly and to what extent different immunosuppressants are absorbed into the blood (this is called pharmacokinetics) in renal transplant candidates who have undergone a laparoscopic sleeve gastrectomy. The immune system is the body's defense against diseases. It also attacks "foreign" tissues such as a transplanted kidney. Immunosuppressant medications such as Astagraf sustained release (XL), Prograf, and mycophenolate mofetil may be given to suppress the immune system following kidney transplantation and prevent rejection of a transplanted kidney. This study is being performed to determine if patients who undergo laparoscopic sleeve gastrectomy need different doses of immunosuppressant medications.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: Astellas Pharma Inc
• Treatments: Immunosuppressive Agents; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

Inclusion Criteria:

1. Female or male patient aged > 18 years old.

2. ESRD patient (on dialysis or preemptive) who is a potential candidate for kidney transplantation

3. Undergone laparoscopic sleeve gastrectomy procedure > 3 months prior to enrollment.

4. Subjects have signed and dated the informed consent to participate in the study.

Exclusion Criteria:

1. Patients taking a drug known to interact with Astagraf XL, Prograf®, or MMF.

2. Patients that have an allergy to Astagraf XL, Prograf®, or MMF.

3. Patients currently taking Astagraf XL, Prograf®, or MMF.

4. Post-surgical leak complication

5. Patients failing to adhere to post laparoscopic sleeve gastrectomy follow-up recommendations and clinic visits

6. Patients with any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation.

7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive laboratory test

8. Currently taking or planning to initiate of any medications that could interfere with tacrolimus and/or mycophenolate blood levels, including over the counter (OTC) medications, herbal supplements, grapefruit or grapefruit juice.

9. Subjects who have been exposed to an investigational therapy within 30 days prior to enrollment or 5 half-lives of the investigational product, whichever is greater.