Kidney Failure, ChronicPhase 4HEMO-TINNCT01930396

Use of Tinzaparin for Anticoagulation in Hemodialysis

A Phase 4 study testing Tinzaparin and Unfractionated Heparin in people with Kidney Failure, Chronic, run by Christine Ribic at 1 site in Canada.

Completed

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

Official record

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Trial summary

The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in hemodialysis patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Chronic
What is being tested?: Tinzaparin and Unfractionated Heparin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 191 participants
Where: 1 siteCanada
Study dates: Sep 2013to Sep 2016
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age >= 18 years
End stage renal disease maintained on outpatient hemodialysis for >= 3 months
Frequency of hemodialysis: 3 times per week
Anticoagulation with an unfractionated heparin protocol for at least 4 weeks
Patient or legal guardian able to provide written consent
Baseline INR <= 1.3
Baseline platelet count >= 80,000 x 10^9/L

Who cannot join

Therapeutic systemic anticoagulation
Clinically apparent bleeding in the last 2 months
High risk of bleeding
Planned major surgery in the next 4 months
Major surgery in the past 48 hours
Pregnant or lactating

Show all 9Show fewer

Child bearing potential
Allergy/intolerance to heparin or history of heparin induced thrombocytopenia
Current participation in a related randomized drug trial

Trial locations and contacts

1 site in 1 country.

Canada1 site

St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

Official title: Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)

Conditions: Kidney Failure, Chronic
Being tested: Tinzaparin, Unfractionated Heparin, Placebo (for Tinzaparin), Placebo (for Unfractionated Heparin)
Keywords: Hemodialysis, Anticoagulation, Tinzaparin, Unfractionated Heparin, Randomized Controlled Trial
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

TinzaparinDrug
Also called Innohep
Unfractionated HeparinDrug
Also called Heparin LEO
Placebo (for Tinzaparin)Drug
0.9% Normal Saline
Placebo (for Unfractionated Heparin)Drug
0.9% Normal Saline

Study groups in NCT01930396
Study group	Role	What they receive
Tinzaparin	Experimental	Not described Receives: Drug: Tinzaparin; Drug: Placebo (for Unfractionated Heparin)
Unfractionated Heparin	Active comparator	Not described Receives: Drug: Unfractionated Heparin; Drug: Placebo (for Tinzaparin)

What is being measured

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

Rate of major, clinically important non-major or minor bleeding
Measured: 26 weeks

Secondary outcomes (1)

Clotting in extracorporeal dialysis circuit
Measured: During Hemodialysis (weekly for 26 weeks)

Timeline

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

Sep 2013Sep 2016

First posted28 Aug 2013 (estimated)
Study startSep 2013
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01930396
Sponsor's protocol ID: 13-7822377
Acronym: HEMO-TIN
Status last verified: Oct 2016
First submitted: 22 Aug 2013
Last updated: 14 Oct 2016
Results posted: No
Data monitoring committee: Yes

Publications

Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
PubMed 38189593

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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Safety and Efficacy of Empagliflozin in Hemodialysis
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Hypothermic Kidney Machine Perfusion With Omnisol
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An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
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All Kidney Failure, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intermittent HEMOdialysis Anticoagulation With TINzaparin Versus Unfractionated Heparin: A Pilot Multicentre Randomized Controlled Trial (HEMO-TIN Trial)
ClinicalTrials.gov ID: NCT01930396
Acronym / sponsor ID: HEMO-TIN / 13-7822377
Conditions: Kidney Failure, Chronic
Keywords: Hemodialysis, Anticoagulation, Tinzaparin, Unfractionated Heparin, Randomized Controlled Trial
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Christine RibicUniversity, hospital or other
Collaborators: McMaster University, LEO Pharma
Study start: Sep 2013
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 28 Aug 2013 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Tinzaparin	Experimental	Drug: Tinzaparin, Drug: Placebo (for Unfractionated Heparin)
Unfractionated Heparin	Active comparator	Drug: Unfractionated Heparin, Drug: Placebo (for Tinzaparin)

Who may qualify

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

Key inclusion criteria (7 listed)

Age >= 18 years
End stage renal disease maintained on outpatient hemodialysis for >= 3 months
Frequency of hemodialysis: 3 times per week
Anticoagulation with an unfractionated heparin protocol for at least 4 weeks
Patient or legal guardian able to provide written consent

Key exclusion criteria (9 listed)

Therapeutic systemic anticoagulation
Clinically apparent bleeding in the last 2 months
High risk of bleeding
Planned major surgery in the next 4 months
Major surgery in the past 48 hours

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
TinzaparinAlso: Innohep	Drug	Tinzaparin
Unfractionated HeparinAlso: Heparin LEO	Drug	Unfractionated Heparin
Placebo (for Tinzaparin)0.9% Normal Saline	Drug	Unfractionated Heparin
Placebo (for Unfractionated Heparin)0.9% Normal Saline	Drug	Tinzaparin

Primary outcome

Rate of major, clinically important non-major or minor bleeding
Time frame: 26 weeks

1 secondary outcome

Clotting in extracorporeal dialysis circuit
Time frame: During Hemodialysis (weekly for 26 weeks)

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 14 Oct 2016.
Derived from this study: PubMed 38189593Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.

Related trials for Kidney Failure, Chronic

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.

Dr. Christine M Ribic, MD, MSc principal investigator

St. Joseph's Healthcare Hamilton/McMaster University

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tinzaparin and Unfractionated Heparin in people with Kidney Failure, Chronic, run by Christine Ribic at 1 site 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 7 inclusion and 9 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 14 Oct 2016. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Rate of major, clinically important non-major or minor bleeding (time frame: 26 weeks). 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 NCT01930396, 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 14 Oct 2016.