Status:
COMPLETED
Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
19-75 years
Phase:
PHASE4
Brief 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 ha...
Detailed Description
Investigators propose a single dose, cross over pharmacokinetic study of Astagraf XL and Prograf® in combination with MMF in RTx candidates that have undergone LSG. Subjects at least three months post...
Eligibility Criteria
Inclusion
- Female or male patient aged \> 18 years old.
- ESRD patient (on dialysis or preemptive) who is a potential candidate for kidney transplantation
- Undergone laparoscopic sleeve gastrectomy procedure \> 3 months prior to enrollment.
- Subjects have signed and dated the informed consent to participate in the study.
Exclusion
- Patients taking a drug known to interact with Astagraf XL, Prograf®, or MMF.
- Patients that have an allergy to Astagraf XL, Prograf®, or MMF.
- Patients currently taking Astagraf XL, Prograf®, or MMF.
- Post-surgical leak complication
- Patients failing to adhere to post laparoscopic sleeve gastrectomy follow-up recommendations and clinic visits
- Patients with any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation.
- 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
- 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.
- 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.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02221583
Start Date
May 1 2014
End Date
February 1 2015
Last Update
May 12 2015
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267