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Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

This study is currently recruiting participants.
Verified November 2012 by University of Colorado, Denver
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: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
Cardiac Transplantation
 Drug: Aliskiren
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Dose-normalized cyclosporine area under the plasma concentration-time curve (AUC) [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 16
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
 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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235910

Contacts
Contact: Christina L Aquilante, Pharm.D. 303-724-6126 christina.aquilante@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Christina Aquilante, Pharm.D.     303-724-6126     christina.aquilante@ucdenver.edu    
Sponsors and Collaborators
University of Colorado, Denver
American Heart Association
Investigators
Principal Investigator: Christina L Aquilante, Pharm.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01235910     History of Changes
Other Study ID Numbers: 10-0746
Study First Received: November 3, 2010
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
Hypertension
Cardiac transplantation
Aliskiren
Cyclosporine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 23, 2013