Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01660295
First received: December 20, 2011
Last updated: August 5, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Renal Insufficiency
Drug: Certoparin 3,000 IU Once Daily
Drug: Certoparin 3,000 IU Twice a Day
Drug: Certoparin 8,000 IU Once Daily
Drug: Certoparin 8,000 IU Twice a Day
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Plasma aXa-Profile: C0 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: December 2011
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Certoparin 3,000 IU Once Daily
Certoparin 3,000 IU subcutaneous injection once daily
Other Name: Mono-Embolex
Drug: Certoparin 8,000 IU Twice a Day
Certoparin 8,000 IU subcutaneous injection twice a day
Other Name: 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.

Drug: Certoparin 3,000 IU Once Daily
Certoparin 3,000 IU subcutaneous injection once daily
Other Name: Mono-Embolex
Drug: Certoparin 3,000 IU Twice a Day
Certoparin 3,000 IU subcutaneous injection twice a day
Other Name: Mono-Embolex
Drug: Certoparin 8,000 IU Once Daily
Certoparin 8,000 IU subcutaneous injection once daily
Other Name: Mono-Embolex
Drug: Certoparin 8,000 IU Twice a Day
Certoparin 8,000 IU subcutaneous injection twice a day
Other Name: Mono-Embolex

  Eligibility

Ages Eligible for Study:   21 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660295

Locations
Hungary
DRC Drug Research Center Ltd., H-8230 Balatonfüred
H-8230 Balatonfüred, Ady E. u., Hungary, 12
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01660295     History of Changes
Other Study ID Numbers: CMEX839BDE07, 2011-001930-40
Study First Received: December 20, 2011
Last Updated: August 5, 2012
Health Authority: Hungary: GYEMSZI - Országos Gyógyszerészeti Intézet

Keywords provided by Novartis:
Severe renal insufficiency certoparin
Severe renal insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Certoparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014