CLINICAL TRIALS PROFILE FOR ASTAGRAF XL

All Clinical Trials for Astagraf Xl

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01962922 ↗	Crossover Study to Compare PK of Once Daily LCP-Tacro Tablets to Generic Tacrolimus Capsules Twice Daily.	Completed	Veloxis Pharmaceuticals	Phase 3	2013-11-01	Open label, prospective, single-center, randomized, two sequence, three period crossover study to compare the steady state pharmacokinetics of LCP-Tacro tables to generic tacrolimus capsules administered twice daily in stable African-American renal transplant patients.
NCT02221583 ↗	Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy	Completed	Astellas Pharma Inc	Phase 4	2014-05-01	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.
NCT02221583 ↗	Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy	Completed	University of Cincinnati	Phase 4	2014-05-01	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.
NCT02339246 ↗	Pharmacokinetic Comparison Of All FK-506 Formulations	Completed	Veloxis Pharmaceuticals	Phase 3	2015-01-01	The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus. Eligible patients will be treated with all three formulations in a pre-defined sequence.
NCT02444143 ↗	A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients	Completed	Astellas Pharma US, Inc.	Phase 4	2015-05-01	Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day dosing regimen. This formulation has the potential to improve compliance. Current dosing recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day administered once daily in the morning. There are no specifications on appropriate dosing in obese patients or on whether to use actual, ideal or and adjusted weight. It will be advantageous to understand the pharmacokinetics of this medication in the obese to determine the appropriate dosing regimen. In this study, obese patients will be randomized to receive tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or adjusted body weight (aBW).
NCT02444143 ↗	A Pharmacokinetic Analysis of Tacrolimus ER Dosing in Obese Kidney Transplant Recipients	Completed	University of Illinois at Chicago	Phase 4	2015-05-01	Tacrolimus extended release (Astagraf) has recently been approved by the FDA as a once a day dosing regimen. This formulation has the potential to improve compliance. Current dosing recommendation for the extended release formulation in renal transplant is 0.15 mg/kg/day administered once daily in the morning. There are no specifications on appropriate dosing in obese patients or on whether to use actual, ideal or and adjusted weight. It will be advantageous to understand the pharmacokinetics of this medication in the obese to determine the appropriate dosing regimen. In this study, obese patients will be randomized to receive tacrolimus extended release 0.15 mg/kg/day based on either ideal body weight (IBW) or adjusted body weight (aBW).

Clinical Trial Conditions for Astagraf Xl

Condition Name

Condition Name for Astagraf Xl
Intervention	Trials
End Stage Renal Disease	2
Kidney Transplantation	2
Renal Failure	2
Heart Failure	1

Condition MeSH

Condition MeSH for Astagraf Xl
Intervention	Trials
Kidney Failure, Chronic	2
Renal Insufficiency	2
Heart Failure	1
Renal Insufficiency, Chronic	1

Clinical Trial Locations for Astagraf Xl

Trials by Country

Trials by Country for Astagraf Xl
Location	Trials
United States	30

Trials by US State

Trials by US State for Astagraf Xl
Location	Trials
Illinois	3
Colorado	2
California	2
New Jersey	2
Ohio	2

Clinical Trial Progress for Astagraf Xl

Clinical Trial Phase

Clinical Trial Phase for Astagraf Xl
Clinical Trial Phase	Trials
Phase 4	6
Phase 3	2
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for Astagraf Xl
Clinical Trial Phase	Trials
Completed	6
Terminated	1
Unknown status	1

Clinical Trial Sponsors for Astagraf Xl

Sponsor Name

Sponsor Name for Astagraf Xl
Sponsor	Trials
Astellas Pharma Inc	3
Veloxis Pharmaceuticals	2
University of Cincinnati	1

Sponsor Type

Sponsor Type for Astagraf Xl
Sponsor	Trials
Industry	7
Other	6