Renal InsufficiencyPhase 1/2NCT01660295
Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
A Phase 1/2 study testing Certoparin 3,000 IU Once Daily, Certoparin 3,000 IU Twice a Day and Certoparin 8,000 IU Once Daily in people with Renal Insufficiency, run by Novartis Pharmaceuticals at 1 site in Hungary.
Trial summary
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Certoparin 3,000 IU Once Daily, Certoparin 3,000 IU Twice a Day and Certoparin 8,000 IU Once Daily
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteHungary
- Study dates
- Dec 2011to Jun 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects OR
- Subjects with severe renal insufficiency
Who cannot join
- Hypersensitivity to study medication
- Genetic abnormality or disease of clotting system
- Prior major surgery or bleeding
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
Hungary1 site
DRC Drug Research Center Ltd., H-8230 Balatonfüred
H-8230 Balatonfüred, Ady E. U., 12
About this study
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
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.
- Conditions
- Renal Insufficiency
- Being tested
- Certoparin 3,000 IU Once Daily, Certoparin 3,000 IU Twice a Day, Certoparin 8,000 IU Once Daily, Certoparin 8,000 IU Twice a Day
- Keywords
- Severe renal insufficiency certoparin, Severe renal insufficiency
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certoparin 3,000 IU Once DailyDrug
Also called Mono-Embolex
Certoparin 3,000 IU subcutaneous injection once daily
Certoparin 3,000 IU Twice a DayDrug
Also called Mono-Embolex
Certoparin 3,000 IU subcutaneous injection twice a day
Certoparin 8,000 IU Once DailyDrug
Also called Mono-Embolex
Certoparin 8,000 IU subcutaneous injection once daily
Certoparin 8,000 IU Twice a DayDrug
Also called Mono-Embolex
Certoparin 8,000 IU subcutaneous injection twice a day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Certoparin 3,000 IU Once Daily; Drug: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660295
- Sponsor's protocol ID
- CMEX839BDE07
- Other IDs
- 2011-001930-40
- Status last verified
- Aug 2012
- First submitted
- 20 Dec 2011
- Last updated
- 8 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01660295
- Acronym / sponsor ID
- CMEX839BDE07
- Conditions
- Renal Insufficiency
- Keywords
- Severe renal insufficiency certoparin, Severe renal insufficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- First posted
- 8 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Certoparin control | Experimental | Drug: Certoparin 3,000 IU Once Daily, Drug: Certoparin 8,000 IU Twice a DayParticipants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria. |
| Certoparin Renal | Experimental | 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 DayParticipants 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjects OR
- Subjects with severe renal insufficiency
Key exclusion criteria (4 listed)
- Hypersensitivity to study medication
- Genetic abnormality or disease of clotting system
- Prior major surgery or bleeding
- Other protocol-defined inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certoparin 3,000 IU Once DailyAlso: Mono-EmbolexCertoparin 3,000 IU subcutaneous injection once daily | Drug | Certoparin Renal, Certoparin control |
| Certoparin 3,000 IU Twice a DayAlso: Mono-EmbolexCertoparin 3,000 IU subcutaneous injection twice a day | Drug | Certoparin Renal |
| Certoparin 8,000 IU Once DailyAlso: Mono-EmbolexCertoparin 8,000 IU subcutaneous injection once daily | Drug | Certoparin Renal |
| Certoparin 8,000 IU Twice a DayAlso: Mono-EmbolexCertoparin 8,000 IU subcutaneous injection twice a day | Drug | Certoparin Renal, Certoparin control |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Certoparin 3,000 IU Once Daily, Certoparin 3,000 IU Twice a Day and Certoparin 8,000 IU Once Daily in people with Renal Insufficiency, run by Novartis Pharmaceuticals at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma aXa-Profile: C0 (time frame: 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2012.