Use Of Fragmin In Hemodialysis

NCT ID: NCT01879618

Last Updated: 2017-03-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Renal Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fragmin

Fragmin given according to the flexible dosing regimen outlined in the protocol

Group Type EXPERIMENTAL

Fragmin

Intervention Type DRUG

variable dosing regimen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fragmin

variable dosing regimen

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* chronic renal failure on hemodialysis

Exclusion Criteria

* significant comorbidities that would prevent a patient from completing the trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Site Status

Horizon Health Network/Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Eastern Regional Health Authority, Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Site Status

Eastern Regional Health Authority, St. Clare's Mercy Hospital

St. John's, Newfoundland and Labrador, Canada

Site Status

Eastern Regional Health Authority, Waterford Hospital

St. John's, Newfoundland and Labrador, Canada

Site Status

Queen Elizabeth II Health Sciences Center (QEII) - VG Site

Halifax, Nova Scotia, Canada

Site Status

William Osler Health System - Bramptom Civic Hospital

Brampton, Ontario, Canada

Site Status

London Health Sciences Centre, University Hospital

London, Ontario, Canada

Site Status

London Health Sciences Centre, Kidney Care Centre

London, Ontario, Canada

Site Status

William Osler Health System

Orangeville, Ontario, Canada

Site Status

Centre intégré de santé et de services sociaux de la Montérégie-Centre

Greenfield Park, Quebec, Canada

Site Status

Centre externe de néphrologie CISSS de la Montérégie-Centre

Greenfield Park, Quebec, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc

Montreal, Quebec, Canada

Site Status

CIUSSS du Nord-de-l'Ile-de-Montreal

Montreal, Quebec, Canada

Site Status

CIUSSS du Nord-de-l'Ile-de-Montreal

Montreal, Quebec, Canada

Site Status

CHU de Quebec (Pavillon Hotel-Dieu de Quebec)

Québec, Quebec, Canada

Site Status

Centre externe de néphrologie CISSS de la Montérégie-Centre

Saint-Lambert, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30542622 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A6301091

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PF-04634817 Renal Impairment Study
NCT01791855 COMPLETED PHASE1
A Renal Impairment Study for PF-06651600
NCT04037865 TERMINATED PHASE1