Chronic Kidney DiseasePhase 4CLOCKNCT02618317
Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
A Phase 4 study testing Heparin Lock Solution, Trissodium Citrate 30% and Minocycline-EDTA 30 mg/ml - 3 mg/ml in people with Chronic Kidney Disease, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence remains high. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Heparin Lock Solution, Trissodium Citrate 30% and Minocycline-EDTA 30 mg/ml - 3 mg/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2013to Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female patients;
- patients with subclavian long term central venous catheter;
- patients on on high-efficiency hemodialysis (BFR= 350 ml; dialisate flow = 500 ml; 3 times; 4-hour sessions).
Who cannot join
- pregnant; patients on oral coagulants; patients aged less than 18 years;
- patients aged more than 75 years
Trial locations and contacts
1 site in 1 country.
About this study
Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence remains high. The purpose of this study was to evaluate two lock solutions on reduction of PF and CRBSI: one, a lock solution combining of the tetracycline antibiotic minocycline with the anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other, trisodium citrate (C) versus H. M-EDTA and C were also evaluated as to their safety versus H.
Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients were blinded to treatment allocation. The primary end-point was a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding and lock solution-related adverse events were the primary safety end points. Logistic Regression was performed to evaluate differences in PF rates among the treatments (SPSS version 13.0, IBM, USA).
Based upon the pilot-study data, the clinical trials has being executed in order to verify whether the three lock solutions have the same performance or not.
Read the detailed description
Methods: 75 CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) will be randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations are M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients are blinded to treatment allocation. The primary end-point is a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI will be recorded. Poor Flow Rate (event/1,000 catheter-day) and CRBSI Rate (event/1,000 catheter-day) will be calculated in each arm. Bleeding and lock solution-related adverse events are also the primary safety end points and their rates (events/1,000 catheter-day) will be calculated. Logistic Regression will be performed to evaluate differences in PF, CRBSI, Bleeding and lock solution-related adverse events rates among the treatments (SPSS version 13.0, IBM, USA).
- Conditions
- Chronic Kidney Disease
- Being tested
- Heparin Lock Solution, Trissodium Citrate 30%, Minocycline-EDTA 30 mg/ml - 3 mg/ml
- Keywords
- renal dialysis
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin Lock SolutionDrug
Also called Hemofol (Traade Mark)
Just after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
Trissodium Citrate 30%Drug
Also called CitraLock(Trade Mark)
ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
Minocycline-EDTA 30 mg/ml - 3 mg/mlDrug
Also called Cath-Safe (Trade Mark)
ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
| Study group | Role | What they receive |
|---|---|---|
| Heparin Lock Solution | Active comparator | Patients on Heparin 1,000 U/ml locking solution, administered at the end of each dialysis session during a 15-week period . Receives: Drug: Heparin Lock Solution |
| Trissodium Citrate 30% | Experimental | Patients on trissodium citrate 30% locking solution, administered at the end of each dialysis session during a 15-week period . Receives: Drug: Trissodium Citrate 30% |
| Minocycline-EDTA 30 mg/ml - 3 mg/ml | Experimental | Patients on Minocycline 30 mg/ml/EDTA 3 mg/ml locking solution, administered at the end of each dialysis session during a 15-week period. Receives: Drug: Minocycline-EDTA 30 mg/ml - 3 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor Blood Flow Rate(BFR)
Reduction of 35 ml in the BFR of 2350 ml on hemodialysis is considered a primary endpoint for this trial
Measured: 100 days
Secondary outcomes (2)
Adverse Drug Reactions Related to lock solutions (ADR)
ADR is considered secondary endpoint for this trial
Measured: 100 days
Cather-Related Blood Stream Infection (CRBSI)
CRBSI is considered secondary endpoint for this trials
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJul 2013
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Marcus Vinicius de Souza Joao Luiz, University of Sao Paulo
- Investigators
- Marcus Luiz, MSc, PharmD, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618317
- Sponsor's protocol ID
- USaoPaulo CLOCK
- Acronym
- CLOCK
- Status last verified
- Nov 2016
- First submitted
- 18 Sep 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness and Safety of Three Lock Solutions for Long-Term Central Venous Catheter for Hemodialysis
- ClinicalTrials.gov ID
- NCT02618317
- Acronym / sponsor ID
- CLOCK / USaoPaulo CLOCK
- Conditions
- Chronic Kidney Disease
- Keywords
- renal dialysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jul 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Dec 2015 (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.
Background: Poor flow (PF) and catheter-related blood stream infections (CRBSI) are highly prevalent among CKD 5D patients with long-term central venous catheters. Heparin (H) catheter lock solutions are commonly used to maintain catheter patency, however PF and CRBSI incidence remains high. The purpose of this study was to evaluate two lock solutions on reduction of PF and CRBSI: one, a lock solution combining of the tetracycline antibiotic minocycline with the anticoagulant/chelation agent EDTA (M-EDTA) versus H; and other, trisodium citrate (C) versus H. M-EDTA and C were also evaluated as to their safety versus H.
Methods:As regards the pilot project, thirty CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) were randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations were M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients were blinded to treatment allocation. The primary end-point was a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI was recorded. Bleeding and lock solution-related adverse events were the primary safety end points. Logistic Regression was performed to evaluate differences in PF rates among the treatments (SPSS version 13.0, IBM, USA).
Based upon the pilot-study data, the clinical trials has being executed in order to verify whether the three lock solutions have the same performance or not.
Detailed description
Methods: 75 CKD 5D patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the Integrated Centre of Nephrology (Guarulhos, Brazil) will be randomized 1:1:1 to receive M-EDTA, C or H locks for 15 weeks. Lock solutions concentrations are M-EDTA 30 mg/ml/3 mg/ml, C 30% (C) and H 1,000 U/ml and both investigators and patients are blinded to treatment allocation. The primary end-point is a 10% reduction in HD blood flow rates (35ml). The frequency of CRBSI will be recorded. Poor Flow Rate (event/1,000 catheter-day) and CRBSI Rate (event/1,000 catheter-day) will be calculated in each arm. Bleeding and lock solution-related adverse events are also the primary safety end points and their rates (events/1,000 catheter-day) will be calculated. Logistic Regression will be performed to evaluate differences in PF, CRBSI, Bleeding and lock solution-related adverse events rates among the treatments (SPSS version 13.0, IBM, USA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heparin Lock Solution | Active comparator | Drug: Heparin Lock SolutionPatients on Heparin 1,000 U/ml locking solution, administered at the end of each dialysis session during a 15-week period . |
| Trissodium Citrate 30% | Experimental | Drug: Trissodium Citrate 30%Patients on trissodium citrate 30% locking solution, administered at the end of each dialysis session during a 15-week period . |
| Minocycline-EDTA 30 mg/ml - 3 mg/ml | Experimental | Drug: Minocycline-EDTA 30 mg/ml - 3 mg/mlPatients on Minocycline 30 mg/ml/EDTA 3 mg/ml locking solution, administered at the end of each dialysis session during a 15-week period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male and female patients;
- patients with subclavian long term central venous catheter;
- patients on on high-efficiency hemodialysis (BFR= 350 ml; dialisate flow = 500 ml; 3 times; 4-hour sessions).
Key exclusion criteria (2 listed)
- pregnant; patients on oral coagulants; patients aged less than 18 years;
- patients aged more than 75 years
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 |
|---|---|---|
| Heparin Lock SolutionAlso: Hemofol (Traade Mark)Just after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution. | Drug | Heparin Lock Solution |
| Trissodium Citrate 30%Also: CitraLock(Trade Mark)ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution. | Drug | Trissodium Citrate 30% |
| Minocycline-EDTA 30 mg/ml - 3 mg/mlAlso: Cath-Safe (Trade Mark)ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution. | Drug | Minocycline-EDTA 30 mg/ml - 3 mg/ml |
Primary outcome
Poor Blood Flow Rate(BFR)
Time frame: 100 days
Reduction of 35 ml in the BFR of 2350 ml on hemodialysis is considered a primary endpoint for this trial
2 secondary outcomes
Adverse Drug Reactions Related to lock solutions (ADR)
Time frame: 100 days
Cather-Related Blood Stream Infection (CRBSI)
Time frame: 100 days
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 2 Dec 2016.
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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.
Marcus Luiz, MSc, PharmD principal investigator
PhD student
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 Heparin Lock Solution, Trissodium Citrate 30% and Minocycline-EDTA 30 mg/ml - 3 mg/ml in people with Chronic Kidney Disease, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 2 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 2 Dec 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 Brazil. 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?
Poor Blood Flow Rate(BFR) (time frame: 100 days). 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 2 Dec 2016.