Pharmacokinetics, Safety and Tolerability of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01568775
First received: March 29, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

This study will assess the pharmacokinetics, safety and tolerability of aliskiren in healthy subjects and patients with End Stage Renal Disease on hemodialysis.


Condition Intervention Phase
End Stage Renal Disease
Drug: Aliskiren
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-label, Parallel Group, Single-sequence Study to Evaluate Pharmacokinetics, Safety, and Tolerability of a Single Dose Administration of Aliskiren (SPP100) in Patients With End Stage Renal Disease on Hemodialysis and Matched Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Pharmacokinetics of aliskiren: Area under the concentration-time curve from time zero to 48- hour post-dose (AUC(0-48hrs)), from time zero to the last measurable concentration sampling time (AUClast), from time zero to infinity (AUCinf) [ Time Frame: 48 hours (period 1) , 1 hour (Period 2) ] [ Designated as safety issue: No ]
    Pharmacokinetics (concentrations of aliskiren in blood and urine) of a single dose of aliskiren in End Stage Renal Disease (ESRD) patients on hemodialysis and matched healthy subjects was analyzed.

  • Pharmacokinetics of aliskiren: Maximum (peak) observed blood and urine drug concentration (Cmax) after single dose administration [ Time Frame: 48 hours (period 1) , 1 hour (Period 2) ] [ Designated as safety issue: No ]
    Pharmacokinetics (concentrations of aliskiren in blood and urine) of a single dose of aliskiren in End Stage Renal Disease (ESRD) patients on hemodialysis and matched healthy subjects was analyzed.

  • Pharmacokinetics of aliskiren: Time to reach maximum (peak) blood and urine drug concentration (Tmax) and elimination half-life (t1/2) after single dose administration [ Time Frame: 48 hours (period 1) , 1 hour (Period 2) ] [ Designated as safety issue: No ]
    Pharmacokinetics (concentrations of aliskiren in blood and urine) of a single dose of aliskiren in End Stage Renal Disease (ESRD) patients on hemodialysis and matched healthy subjects was analyzed.


Secondary Outcome Measures:
  • Effect of timing of hemodialysis on the PK of aliskiren in End Stage Renal Disease (ESRD) patients [ Time Frame: 48 hrs (Period 1), 1 hr (Period 2) ] [ Designated as safety issue: No ]
  • Number of patients with adverse events, serious adverse events and death [ Time Frame: maximum 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren
All patient and subjects received single dose of aliskiren 300 mg in treatment period.
Drug: Aliskiren
All patient and subjects received single dose of aliskiren 300 mg in treatment period.
Other Name: SPP100

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female subjects must be of non-child bearing potential, defined as postmenopausal women with no regular menstrual bleeding for at least 1 year prior to screening or female subjects surgically sterilized at least 6 months prior to screening. All female subjects must have negative pregnancy results at screening.
  2. Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 to 30 kg/m2
  3. Vital signs after 3 minutes resting in the supine position (laying down) should be within the following ranges:

    • Oral body temperature between 35.0-37.8ºC
    • Systolic blood pressure, 95-140 mmHg
    • Diastolic blood pressure, 60-90 mmHg Blood pressure and pulse will be taken again in the standing position. After 3 minutes standing, there shall be no more than a 20 mm Hg drop in systolic or 10 mmHg drop in diastolic blood pressure associated with symptomatic postural hypotension.
  4. Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study. Subjects must be able to understand and sign the written informed consent.
  5. Health subjects must be in good health as determined by past medical history, physical examination, vital signed assessments, electrocardiogram, and laboratory tests at screening.
  6. Patients with End Stage Renal Disease who have been on intermittent hemodialysis three times a week for at least three months and are in relatively good health.

Exclusion Criteria:

  1. Smokers who report cigarette use of more than 5 cigarettes per day.
  2. Use of aliskiren within 2 weeks prior to study entry.
  3. Participation in any clinical investigation within 3 months prior to initial dosing.
  4. Hemoglobin levels outside 11-14 mg/dL
  5. A history/presence of diabetes mellitus
  6. A past medical history of arrhythmias, heart failure, unstable angina pectoris, stroke, or myocardial infarction within 6 months of the start of the study.
  7. A past medical history of significant electrocardiogram abnormalities.
  8. Recent (within the last 3 years) and/or recurrent history/presence of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc).
  9. Recent (within the last 3 years) and/or recurrent history/presence of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
  10. Significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to aliskiren.
  11. Total white blood cell (WBC) count outside the normal laboratory reference range.
  12. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
  13. A positive Hepatitis B surface antigen or Hepatitis C test result.
  14. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening on Day -1 of each treatment period.
  15. Consumption of grapefruit or grapefruit juice within 14 days prior to dosing.
  16. Lactating and breastfeeding females.
  17. History of head and neck angioedema.
  18. Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568775

Locations
Germany
Charité Universitätsmedizin
Berlin, Germany
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01568775     History of Changes
Other Study ID Numbers: CSPP100A2262, 2009-014358-13
Study First Received: March 29, 2012
Last Updated: March 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
End Stage Renal Disease
Dialysis
aliskiren
SPP100A

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 22, 2014