NCT01660295

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

December 20, 2011

Last Update Submit

August 5, 2012

Conditions

Renal Insufficiency

Keywords

Severe renal insufficiency certoparinSevere renal insufficiency

Outcome Measures

Primary Outcomes (4)

  • 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.

    5 days

  • 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.

    5 days

  • 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.

    5 days

  • 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.

    5 days

Study Arms (2)

Certoparin control

EXPERIMENTAL

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 DailyDrug: Certoparin 8,000 IU Twice a Day

Certoparin Renal

EXPERIMENTAL

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 DailyDrug: Certoparin 3,000 IU Twice a DayDrug: Certoparin 8,000 IU Once DailyDrug: Certoparin 8,000 IU Twice a Day

Interventions

Certoparin 3,000 IU Once DailyDRUG

Certoparin 3,000 IU subcutaneous injection once daily

Also known as: Mono-Embolex
Certoparin RenalCertoparin control
Certoparin 3,000 IU Twice a DayDRUG

Certoparin 3,000 IU subcutaneous injection twice a day

Also known as: Mono-Embolex
Certoparin Renal
Certoparin 8,000 IU Once DailyDRUG

Certoparin 8,000 IU subcutaneous injection once daily

Also known as: Mono-Embolex
Certoparin Renal
Certoparin 8,000 IU Twice a DayDRUG

Certoparin 8,000 IU subcutaneous injection twice a day

Also known as: Mono-Embolex
Certoparin RenalCertoparin control

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects OR
  • Subjects with severe renal insufficiency

You may not qualify if:

  • Hypersensitivity to study medication
  • Genetic abnormality or disease of clotting system
  • Prior major surgery or bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DRC Drug Research Center Ltd., H-8230 Balatonfüred

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

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

certoparin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2011

First Posted

August 8, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2012

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations

HU(1)