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Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

Primary Purpose

Renal Insufficiency

Status
Completed
Phase
Phase 1
Locations
Hungary
Study Type
Interventional
Intervention
Certoparin 3,000 IU Once Daily
Certoparin 3,000 IU Twice a Day
Certoparin 8,000 IU Once Daily
Certoparin 8,000 IU Twice a Day
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency focused on measuring Severe renal insufficiency certoparin, Severe renal insufficiency

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • DRC Drug Research Center Ltd., H-8230 Balatonfüred

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Certoparin control

Certoparin Renal

Arm Description

Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.

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.

Outcomes

Primary Outcome Measures

Plasma aXa-Profile: C0
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.
Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)
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.
Plasma aXa-Profile: Cmax
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.
Plasma aXa-Profile: AUC
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.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2011
Last Updated
August 5, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01660295
Brief Title
Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
Severe renal insufficiency certoparin, Severe renal insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Certoparin control
Arm Type
Experimental
Arm Description
Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
Arm Title
Certoparin Renal
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Certoparin 3,000 IU Once Daily
Other Intervention Name(s)
Mono-Embolex
Intervention Description
Certoparin 3,000 IU subcutaneous injection once daily
Intervention Type
Drug
Intervention Name(s)
Certoparin 3,000 IU Twice a Day
Other Intervention Name(s)
Mono-Embolex
Intervention Description
Certoparin 3,000 IU subcutaneous injection twice a day
Intervention Type
Drug
Intervention Name(s)
Certoparin 8,000 IU Once Daily
Other Intervention Name(s)
Mono-Embolex
Intervention Description
Certoparin 8,000 IU subcutaneous injection once daily
Intervention Type
Drug
Intervention Name(s)
Certoparin 8,000 IU Twice a Day
Other Intervention Name(s)
Mono-Embolex
Intervention Description
Certoparin 8,000 IU subcutaneous injection twice a day
Primary Outcome Measure Information:
Title
Plasma aXa-Profile: C0
Description
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.
Time Frame
5 days
Title
Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)
Description
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.
Time Frame
5 days
Title
Plasma aXa-Profile: Cmax
Description
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.
Time Frame
5 days
Title
Plasma aXa-Profile: AUC
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
DRC Drug Research Center Ltd., H-8230 Balatonfüred
City
H-8230 Balatonfüred
State/Province
Ady E. u.
ZIP/Postal Code
12
Country
Hungary

12. IPD Sharing Statement

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Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

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