Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects

Renal Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660295
• Other study ID #: CMEX839BDE07
• Secondary ID: 2011-001930-40
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 20, 2011
• Last updated: August 5, 2012
• Start date: December 2011

Study information

• Verified date: August 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: GYEMSZI - Országos Gyógyszerészeti Intézet
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• Certoparin 3,000 IU Once Daily
Certoparin 3,000 IU subcutaneous injection once daily
• Certoparin 3,000 IU Twice a Day
Certoparin 3,000 IU subcutaneous injection twice a day
• Certoparin 8,000 IU Once Daily
Certoparin 8,000 IU subcutaneous injection once daily
• Certoparin 8,000 IU Twice a Day
Certoparin 8,000 IU subcutaneous injection twice a day

Locations

Country	Name	City	State
Hungary	DRC Drug Research Center Ltd., H-8230 Balatonfüred	H-8230 Balatonfüred	Ady E. u.

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma aXa-Profile: C0	Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (t = 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	No
Primary	Dose regimen, systemic total exposure to aXa (AUC0-t,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-t,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects.	5 days	No
Primary	Plasma aXa-Profile: Cmax	Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (t = 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	No
Primary	Plasma aXa-Profile: AUC	Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (t = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-t,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.	5 days	No