Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01660295

Enrollment

Registered

2012-08-08

Start date

2011-12-31

Completion date

Unknown

Last updated

2012-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

Keywords

Severe renal insufficiency certoparin, Severe renal insufficiency

Brief summary

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

Interventions

DRUGCertoparin 3,000 IU Once Daily

Certoparin 3,000 IU subcutaneous injection once daily

DRUGCertoparin 3,000 IU Twice a Day

Certoparin 3,000 IU subcutaneous injection twice a day

DRUGCertoparin 8,000 IU Once Daily

Certoparin 8,000 IU subcutaneous injection once daily

DRUGCertoparin 8,000 IU Twice a Day

Certoparin 8,000 IU subcutaneous injection twice a day

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

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

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026