Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01235910
Recruitment Status : Terminated (Study was stopped early due to difficulty finding patients who met I/E criteria.)
First Posted : November 8, 2010
Results First Posted : August 18, 2015
Last Update Posted : December 4, 2017
American Heart Association
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Cardiac Transplantation Drug: Aliskiren Phase 4

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. This 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Pharmacology of Aliskiren in Combination With Cyclosporine in Cardiac Transplantation
Study Start Date : May 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 (cyclosporine)

Primary Outcome Measures :
  1. Dose-normalized Cyclosporine Area Under the Plasma Concentration-time Curve (AUC) [ Time Frame: 7 days, 14 days, 30 days (End of Study) ]
    The study was stopped due to difficulty finding patients who met the strict inclusion criteria. Only one patient was started on the study drug. as a result we did not analyze any cyclosporine PK (e.g.(AUCs) for this study.

Secondary Outcome Measures :
  1. Aliskiren Plasma Concentrations [ Time Frame: 2 weeks ]
    Maximum plasma concentration; area under the concentration-time curve, half-life, oral clearance

  2. Blood Pressure [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01235910

United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
American Heart Association
Principal Investigator: Christina L Aquilante, Pharm.D. University of Colorado, Denver

Responsible Party: University of Colorado, Denver Identifier: NCT01235910     History of Changes
Other Study ID Numbers: 10-0746
First Posted: November 8, 2010    Key Record Dates
Results First Posted: August 18, 2015
Last Update Posted: December 4, 2017
Last Verified: October 2017

Keywords provided by University of Colorado, Denver:
Cardiac transplantation

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors