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Completed

NCT Number: NCT01660295

Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

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

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

DRC Drug Research Center Ltd., H-8230 Balatonfüred

H-8230 Balatonfüred, Ady E. U., 12, Hungary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certoparin 3,000 IU Once Daily

Drug

Certoparin 3,000 IU subcutaneous injection once daily

Other names: Mono-Embolex

Certoparin 3,000 IU Twice a Day

Drug

Certoparin 3,000 IU subcutaneous injection twice a day

Other names: Mono-Embolex

Certoparin 8,000 IU Once Daily

Drug

Certoparin 8,000 IU subcutaneous injection once daily

Other names: Mono-Embolex

Certoparin 8,000 IU Twice a Day

Drug

Certoparin 8,000 IU subcutaneous injection twice a day

Other names: Mono-Embolex

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
First posted
Aug 8, 2012
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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