Renal Insufficiency, ChronicNCT02731209
Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter Delay the Need for Kidney Dialysis
A study testing urinary catheter in people with Renal Insufficiency, Chronic, run by Assaf Harofeh MC at 1 site in Israel.
Trial summary
The aim of the investigators work is to describe the urodynamic results in the CKD (chronic kidney disease) grade 4 patients and to verify observations that urinary catheter may improve kidney function in those patients. 100 patients with CKD grade 4 will do urodynamic examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- urinary catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2016to Feb 2017
- Phase
- Interventional
- 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
- chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) <30)
- eligible to sign a consent form
Who cannot join
- non controlled Diabetes Melitus (HbA1C>10%)
- not controlled HTN (Hypertension)
- cardiovascular event requiring cardiac stenting
- renal hydronephrosis or post void rest > 200CC according to US (Ultrasound)
- acute renal failure
- not eligible for urodynamics for any reason
- constant urinary catheter for any reason
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Asaf ha Rofeh, MC
Zrifin, 70300
Ilya Baberashvili, Doctor of Medicine, +972537346133, iliav@asaf.health.gov.il
Guy Verhovsky, MD, +972548137811, guy.verchovsky@gmail.com
About this study
Official title: Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter in Chronic Kidney Disease Patients Grade 4 Delay the Need for Kidney Dialysis
The aim of the investigators work is to describe the urodynamic results in the CKD (chronic kidney disease) grade 4 patients and to verify observations that urinary catheter may improve kidney function in those patients.
100 patients with CKD grade 4 will do urodynamic examination.
All patients will be randomized into two groups / the intervention group that will be inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be monitored by creatinin values and the investigators will measure the time to dialysis in the two groups.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- urinary catheter
- 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.
urinary catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| catheter insertion for 2 weeks | Experimental | 50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks Receives: Device: urinary catheter |
| follow up | No intervention | 50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist |
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney function change
measured by creatinine values mg/dL
Measured: At the time of urinary catheter insertion. Two weeks from the insertion and than after 8,16, 24, 32, 40 and 48 weeks after the urinary catheter insertion. (at total 52 weeks of follow up)
Secondary outcomes (1)
time to dialysis
Measured: at least 1 year from the time of catheter insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf Harofeh MC
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Assaf Harofeh MC, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731209
- Sponsor's protocol ID
- 0308-15-ASF
- Status last verified
- Apr 2016
- First submitted
- 22 Feb 2016
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Urodynamic Changes in Chronic Kidney Disease Patients and Does Insertion of Urinary Catheter in Chronic Kidney Disease Patients Grade 4 Delay the Need for Kidney Dialysis
- ClinicalTrials.gov ID
- NCT02731209
- Acronym / sponsor ID
- 0308-15-ASF
- Conditions
- Renal Insufficiency, Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf Harofeh MCOther government
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- First posted
- 7 Apr 2016 (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.
The aim of the investigators work is to describe the urodynamic results in the CKD (chronic kidney disease) grade 4 patients and to verify observations that urinary catheter may improve kidney function in those patients.
100 patients with CKD grade 4 will do urodynamic examination.
All patients will be randomized into two groups / the intervention group that will be inserted urinary catheter for 2 weeks and the follow up group. Kidney function will be monitored by creatinin values and the investigators will measure the time to dialysis in the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| catheter insertion for 2 weeks | Experimental | Device: urinary catheter50 randomized patients that will do urodynamic urinary examination and will be inserted urinary catheter for 2 weeks |
| follow up | No intervention | –50 randomized patients that will do urodynamic urinary examination and will be regularly followed by nephrologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18
- chronic kidney disease grade 4-5 (eGFR (estimated glomerular filtration rate) <30)
- eligible to sign a consent form
Key exclusion criteria (7 listed)
- non controlled Diabetes Melitus (HbA1C>10%)
- not controlled HTN (Hypertension)
- cardiovascular event requiring cardiac stenting
- renal hydronephrosis or post void rest > 200CC according to US (Ultrasound)
- acute renal failure
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 |
|---|---|---|
| urinary catheter | Device | catheter insertion for 2 weeks |
Primary outcome
kidney function change
Time frame: At the time of urinary catheter insertion. Two weeks from the insertion and than after 8,16, 24, 32, 40 and 48 weeks after the urinary catheter insertion. (at total 52 weeks of follow up)
measured by creatinine values mg/dL
1 secondary outcome
time to dialysis
Time frame: at least 1 year from the time of catheter insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urinary catheter in people with Renal Insufficiency, Chronic, run by Assaf Harofeh MC at 1 site in Israel.
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 7 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: status not confirmed, as of the sponsor's last update on 7 Apr 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kidney function change (time frame: At the time of urinary catheter insertion. Two weeks from the insertion and than after 8,16, 24, 32, 40 and 48 weeks after the urinary catheter insertion. (at total 52 weeks of follow up)). 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 7 Apr 2016.