Use Of Fragmin In Hemodialysis

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01879618
• Collaborator: (none)
• Enrollment: 152
• Locations: 19
• Arm: 1
• Duration (Months): 29
• Patients Per Site: 8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Failure	Drug: Fragmin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fragmin Fragmin given according to the flexible dosing regimen outlined in the protocol	Drug: Fragmin; variable dosing regimen

Outcome Measures

Primary Outcome Measures

1. Mean Percent of Successful HD Sessions [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.

Secondary Outcome Measures

1. Mean Percent of HD Sessions With an Acceptable Dose [20 HD sessions (up to 4 hours)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• chronic renal failure on hemodialysis

Exclusion Criteria:

• significant comorbidities that would prevent a patient from completing the trial

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01879618
• Other Study ID Numbers: A6301091
• First Posted: Jun 18, 2013
• Last Update Posted: Mar 10, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Pfizer: Fragmin; dalteparin; hemodialysis; anticoagulation; Renal Failure
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Dalteparin

Study Results

Participant Flow

Recruitment Details	The study was conducted in 12 sites in Canada, 10 of which enrolled participants. A total of 152 participants with chronic renal failure, who had at least 30 previous days of hemodialysis (HD) and had received ≤10,000 IU unfractionated heparin or low molectular weight heparin for anticoagulation during the past month were enrolled in the study.
Pre-assignment Detail	The Screening Visit was performed within 9 days preceding first HD session where FRAGMIN was administered. The Final Study Visit took place 5 to 15 days after the final study HD session where the participant was treated with Fragmin (# 20 or the last HD session that was completed, if the partcipant prematurely terminated).

Arm/Group Title	FRAGMIN
Arm/Group Description	Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
Period Title: Overall Study
STARTED	152
COMPLETED	131
NOT COMPLETED	21

Baseline Characteristics

Arm/Group Title	FRAGMIN
Arm/Group Description	Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
Overall Participants	152
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.1 (14.7)
Sex: Female, Male (Count of Participants)
Female	46 30.3%
Male	106 69.7%

Outcome Measures

1. Primary Outcome

Title	Mean Percent of Successful HD Sessions
Description	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.
Time Frame	20 HD sessions (up to 4 hours)

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	FRAGMIN
Arm/Group Description	Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
Measure Participants	151
Mean (95% Confidence Interval) [Percentage of HD Sessions]	99.9

2. Secondary Outcome

Title	Mean Percent of HD Sessions With an Acceptable Dose
Description	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.
Time Frame	20 HD sessions (up to 4 hours)

Outcome Measure Data

Analysis Population Description

FAS was used for all efficacy analyses which included all participants who received at least one dose of study medication. For this endpoint, there were 2630 evaluable HD sessions from 148 participants.

Arm/Group Title	FRAGMIN
Arm/Group Description	Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
Measure Participants	148
Mean (95% Confidence Interval) [Percentage of HD sessions]	89.8

Adverse Events

Time Frame	From screening (-9 days) up to 30 days after last dose of study drug.
Arm/Group Title	FRAGMIN
Arm/Group Description	Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
All Cause Mortality
	FRAGMIN
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	FRAGMIN
	Affected / at Risk (%)	# Events
Total	3/152 (2%)
Cardiac disorders
Atrial fibrillation	1/152 (0.7%)	1
Infections and infestations
Pneumonia	1/152 (0.7%)	1
Influenza	1/152 (0.7%)	1
Other (Not Including Serious) Adverse Events
	FRAGMIN
	Affected / at Risk (%)	# Events
Total	27/152 (17.8%)
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage	19/152 (12.5%)	19
Vascular disorders
Hypotension	8/152 (5.3%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.