Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

This study has been terminated.
(The study was stopped early due to difficulty finding patients who met inclusion/exclusion criteria. Only one patient was started on study drug.)
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01235910
First received: November 3, 2010
Last updated: December 9, 2013
Last verified: November 2012

November 3, 2010
December 9, 2013
May 2011
December 2012   (final data collection date for primary outcome measure)
Dose-normalized cyclosporine area under the plasma concentration-time curve (AUC) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01235910 on ClinicalTrials.gov Archive Site
  • Aliskiren plasma concentrations [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Maximum plasma concentration; area under the concentration-time curve, half-life, oral clearance
  • Blood pressure [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation
Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

The purpose of this study is to evaluate the safety and efficacy of the blood pressure medication, aliskiren, in heart transplant patients. In terms of safety, the investigators will evaluate the blood levels of aliskiren and determine if aliskiren alters the blood levels of the anti-rejection medication, cyclosporine, in these patients. In terms of efficacy, the investigators will determine how well aliskiren lowers blood pressure in heart transplant patients.

Hypertension is a major complication following cardiac transplantation, with a prevalence of 93% at 5 years post-transplant. Post-cardiac transplant hypertension is due to multiple factors such as use of cyclosporine, chronic kidney disease, and denervation. Hypertension in this population is difficult to treat, and most patients require therapy with multiple antihypertensive agents in order to achieve adequate blood pressure control. Aliskiren, a direct renin inhibitor, is a novel antihypertensive agent with a unique mechanism of action and potent blood pressure-lowering effects. As such, aliskiren is an attractive treatment option for post-cardiac transplant hypertension. Our study will characterize the pharmacokinetic drug-drug interaction profile, pharmacodynamics, and safety of aliskiren 75 mg daily (low-dose) and 150 mg daily, when given in combination with cyclosporine, in cardiac transplant patients.

Interventional
Phase 4
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hypertension
  • Cardiac Transplantation
Drug: Aliskiren
Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Other Names:
  • Tekturna (aliskiren)
  • Neoral (cycolosporine)
1
Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Intervention: Drug: Aliskiren
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 6 months or more since cardiac transplant
  • Clinically stable from a transplant perspective
  • Maintained on a stable immunosuppressant regimen containing cyclosporine + an antiproliferative agent (e.g., azathioprine, mycophenolate), +/- an oral steroid
  • Hypertension, as defined by a seated average systolic blood pressure of ≥ 140 mm Hg and a seated average diastolic blood pressure of ≥ 90 mm Hg, based on 3 separate measurements, spaced 2 minutes apart.

Exclusion Criteria:

  • Clinical instability from a cardiac transplant perspective
  • Contraindications to aliskiren therapy
  • Conditions that may increase the risk of aliskiren adverse effects
  • Severe hypertension
  • Concomitant medications known to increase or decrease aliskiren plasma exposure.
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01235910
10-0746
No
University of Colorado, Denver
University of Colorado, Denver
American Heart Association
Principal Investigator: Christina L Aquilante, Pharm.D. University of Colorado, Denver
University of Colorado, Denver
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP