Chronic Renal FailurePhase 3NCT01879618

Use Of Fragmin In Hemodialysis

A Phase 3 study testing Fragmin in people with Chronic Renal Failure, run by Pfizer at 19 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Chronic Renal Failure
What is being tested?: Fragmin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 152 participants
Where: 19 sitesCanada
Study dates: Oct 2013to Mar 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

chronic renal failure on hemodialysis

Who cannot join

significant comorbidities that would prevent a patient from completing the trial

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Canada19 sites

William Osler Health System - Bramptom Civic Hospital
Brampton, Ontario, L6R 3J7
Royal Alexandra Hospital
Edmonton, Alberta, T5G 0B8
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8
Centre intégré de santé et de services sociaux de la Montérégie-Centre
Greenfield Park, Quebec, J4V 2H1
Centre externe de néphrologie CISSS de la Montérégie-Centre
Greenfield Park, Quebec, J4V 3M3
Queen Elizabeth II Health Sciences Center (QEII) - VG Site
Halifax, Nova Scotia, B3H 2Y9
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5
London Health Sciences Centre, Kidney Care Centre
London, Ontario, N6K 1M6
Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc
Montreal, Quebec, H2X 3J4
CIUSSS du Nord-de-l'Ile-de-Montreal
Montreal, Quebec, H3M 3E3
CIUSSS du Nord-de-l'Ile-de-Montreal
Montreal, Quebec, H4J 1C5
William Osler Health System
Orangeville, Ontario, L9W 4X9
CHU de Quebec (Pavillon Hotel-Dieu de Quebec)
Québec, Quebec, G1R 2J6
Horizon Health Network/Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Centre externe de néphrologie CISSS de la Montérégie-Centre
Saint-Lambert, Quebec, J4R 2L1
Eastern Regional Health Authority, Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Eastern Regional Health Authority, St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8
Eastern Regional Health Authority, Waterford Hospital
St. John's, Newfoundland and Labrador, A1E 4J8

Other trials in Canada

About this study

Official title: A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study

The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.

Conditions: Chronic Renal Failure
Being tested: Fragmin
Keywords: Fragmin, dalteparin, hemodialysis, anticoagulation, Renal Failure
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FragminDrug
variable dosing regimen

Study groups in NCT01879618
Study group	Role	What they receive
Fragmin	Experimental	Fragmin given according to the flexible dosing regimen outlined in the protocol Receives: Drug: Fragmin

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Percent of Successful HD Sessions
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.
Measured: 20 HD sessions (up to 4 hours)

Secondary outcomes (1)

Mean Percent of HD Sessions With an Acceptable Dose
A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.
Measured: 20 HD sessions (up to 4 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Mar 2016

First posted18 Jun 2013 (estimated)
Study startOct 2013
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
More trials run by PfizerThe 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 152 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01879618
Sponsor's protocol ID: A6301091
Status last verified: Jan 2017
First submitted: 13 Jun 2013
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Soroka S, Agharazii M, Donnelly S, Roy L, Muirhead N, Cournoyer S, MacKinnon M, Pannu N, Barrett B, Madore F, Tennankore K, Wilson JA, Hilton F, Sherman N, Wolter K, Orazem J, Feugere G. An Adjustable Dalteparin Sodium Dose Regimen for the Prevention of Clotting in the Extracorporeal Circuit in Hemodialysis: A Clinical Trial of Safety and Efficacy (the PARROT Study). Can J Kidney Health Dis. 2018 Nov 4;5:2054358118809104. doi: 10.1177/2054358118809104. eCollection 2018.
PubMed 30542622

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Renal Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study
ClinicalTrials.gov ID: NCT01879618
Acronym / sponsor ID: A6301091
Conditions: Chronic Renal Failure
Keywords: Fragmin, dalteparin, hemodialysis, anticoagulation, Renal Failure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 152 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 18 Jun 2013 (estimated)
Results: Posted 29 Dec 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fragmin	Experimental	Drug: FragminFragmin given according to the flexible dosing regimen outlined in the protocol

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

chronic renal failure on hemodialysis

Key exclusion criteria (1 listed)

significant comorbidities that would prevent a patient from completing the trial

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
Fragminvariable dosing regimen	Drug	Fragmin

Primary outcome

Mean Percent of Successful HD Sessions
Time frame: 20 HD sessions (up to 4 hours)
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.

1 secondary outcome

Mean Percent of HD Sessions With an Acceptable Dose
Time frame: 20 HD sessions (up to 4 hours)

Results and safety

Results posted to the registry on 29 Dec 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FRAGMIN	152	131

Primary outcome: Mean Percent of Successful HD Sessions

Time frame: 20 HD sessions (up to 4 hours). Mean (95% Confidence Interval). Unit: Percentage of HD Sessions

Measure	FRAGMIN n = 151
Value	99.9 (99.7 to 100)

Population analysed: The Full Analysis Set (FAS) was used for all efficacy analyses which included all participants who received at least one dose of study medication. There were 2776 HD sessions from 151 participants included in the primary analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From screening (-9 days) up to 30 days after last dose of study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FRAGMIN	3 of 152 (2%)	27 of 152 (17.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30542622Soroka S, Agharazii M, Donnelly S, Roy L, Muirhead N, Cournoyer S, MacKinnon M, Pannu N, Barrett B, Madore F, Tennankore K, Wilson JA, Hilton F, Sherman N, Wolter K, Orazem J, Feugere G. An Adjustable Dalteparin Sodium Dose Regimen for the Prevention of Clotting in the Extracorporeal Circuit in Hemodialysis: A Clinical Trial of Safety and Efficacy (the PARROT Study). Can J Kidney Health Dis. 2018 Nov 4;5:2054358118809104. doi: 10.1177/2054358118809104. eCollection 2018.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Chronic Renal Failure

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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.

Pfizer CT.gov Call Center study director

Pfizer

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fragmin in people with Chronic Renal Failure, run by Pfizer at 19 sites in Canada.

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 1 inclusion and 1 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Canada. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Percent of Successful HD Sessions (time frame: 20 HD sessions (up to 4 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01879618, which also lists 1 linked publication.

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 10 Mar 2017.