Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

August 5, 2012 updated by: Novartis Pharmaceuticals

An Open-label, Single Center, Parallel-group Study to Compare the Single- and Repeated-dose Pharmacokinetics of Stepwise Increasing Doses of Subcutaneous Certoparin (3000 IU o.d., 3000 IU b.i.d., 8000 IU o.d., and 8000 IU b.i.d.) in Subjects With Severe Renal Insufficiency and Healthy Subjects

This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.

Study Overview

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ady E. u.
      • H-8230 Balatonfüred, Ady E. u., Hungary, 12
        • DRC Drug Research Center Ltd., H-8230 Balatonfüred

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Healthy subjects OR
  • Subjects with severe renal insufficiency

Exclusion criteria:

  • Hypersensitivity to study medication
  • Genetic abnormality or disease of clotting system
  • Prior major surgery or bleeding
  • Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Certoparin control
Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
Certoparin 3,000 IU subcutaneous injection once daily
Other Names:
  • Mono-Embolex
Certoparin 8,000 IU subcutaneous injection twice a day
Other Names:
  • Mono-Embolex
Experimental: Certoparin Renal

Participants receive dose escalation upon medical criteria qualification at each period:

Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.

Certoparin 3,000 IU subcutaneous injection once daily
Other Names:
  • Mono-Embolex
Certoparin 8,000 IU subcutaneous injection twice a day
Other Names:
  • Mono-Embolex
Certoparin 3,000 IU subcutaneous injection twice a day
Other Names:
  • Mono-Embolex
Certoparin 8,000 IU subcutaneous injection once daily
Other Names:
  • Mono-Embolex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma aXa-Profile: C0
Time Frame: 5 days
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
5 days
Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)
Time Frame: 5 days
Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d. IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects.
5 days
Plasma aXa-Profile: Cmax
Time Frame: 5 days
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel.
5 days
Plasma aXa-Profile: AUC
Time Frame: 5 days
Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

August 5, 2012

First Posted (Estimate)

August 8, 2012

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 5, 2012

Last Verified

August 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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