Chronic Kidney FailureNCT02033798
The Effect of Daily Tamsulosin 0.2mg Administration on Renal Function in Patients With Benign Prostatic Hyperplasia
A study testing Tamsulosin in people with Chronic Kidney Failure and Prostatic Hyperplasia, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether medical treatment for bladder outlet obstruction is effective in improvement of glomerular filtration rate and/or proteinuria. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Chronic Kidney Failure, Prostatic Hyperplasia
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Jun 2016
- 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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with low urinary tract symptoms aged between 40 and 80
- Estimated glomerular filtration rate < 60 or evidence of proteinuria
- Bladder outlet obstruction index > 40, Schäfer grade 2 or more, maximal flow rate lower than 10 cc/s or postvoid residual urine > 100cc
Who cannot join
- Bladder outlet obstruction index less than 40, Schäfer grade 0 or 1, maximal flow rate higher than 10 ml/s and postvoid residual urine less than 100cc
- Want surgical procedure
- Evidence of prostate cancer or bladder cancer
- Major depressive disorder, Dementia, Parkinson's disease or neurological deficits
- History of pelvic irradiation
- Uncontrolled diabetes mellitus or hypertension
- Symptomatic orthostatic hypotension
Trial locations and contacts
1 site in 1 country.
South Korea1 site
St. Vincent's Hospital
Suwon, Gyeonggi-do, 442-723
Seung-Ju Lee Lee, MD, PhD, 82-31-249-8305, lee.seungju@gmail.com
About this study
Official title: Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure
The purpose of this study is to determine whether medical treatment for bladder outlet obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.
Read the detailed description
Urodynamic parameters including maximal flow rate, compliance (infused volume gradient divided by bladder pressure gradient during cystometry), maximal detrusor pressure, bladder outlet obstruction index and Schäfer grade will be checked.
Estimated glomerular filtration rate and urinary protein to creatinine ratio will be checked.
International prostate symptom score will be checked.
- Conditions
- Chronic Kidney Failure, Prostatic Hyperplasia
- Being tested
- Tamsulosin
- Keywords
- Urodynamics, Glomerular Filtration Rate
- Medical subject headings
- Kidney Failure, Chronic, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Harnal D, Tamsnal
Once Daily 0.2mg per oral for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin | Experimental | The dosage form of Tamsulosin is tablet, dosage is 0.2mg, frequency is once daily and duration is 6 months. Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal flow rate
This parameter can be obtained from urodynamic study.
Measured: 6 months
Maximal detrusor pressure
This parameter can be obtained from urodynamic study.
Measured: 6 months
Bladder outlet obstruction index
This parameter can be obtained from urodynamic study.
Measured: 6 months
schäfer grade
This parameter can be obtained from urodynamic study.
Measured: 6 months
Compliance
This parameter can be obtained from urodynamic study.
Measured: 6 months
Secondary outcomes (2)
Estimated glomerular filtration rate
Measured: 6 months
Urinary protein to creatinine ratio
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Ju Lee, The Catholic University of Korea
- Investigators
- Seung-Ju Lee, MD, PhD, Study chair, The Catholic University of KoreaDong Sup Lee, MD, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033798
- Sponsor's protocol ID
- L201401N2
- Status last verified
- Jan 2014
- First submitted
- 8 Jan 2014
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medical Treatment for Benign Prostatic Hyperplasia on Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT02033798
- Acronym / sponsor ID
- L201401N2
- Conditions
- Chronic Kidney Failure, Prostatic Hyperplasia
- Keywords
- Urodynamics, Glomerular Filtration Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 13 Jan 2014 (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 purpose of this study is to determine whether medical treatment for bladder outlet obstruction is effective in improvement of glomerular filtration rate and/or proteinuria.
Detailed description
Urodynamic parameters including maximal flow rate, compliance (infused volume gradient divided by bladder pressure gradient during cystometry), maximal detrusor pressure, bladder outlet obstruction index and Schäfer grade will be checked.
Estimated glomerular filtration rate and urinary protein to creatinine ratio will be checked.
International prostate symptom score will be checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Experimental | Drug: TamsulosinThe dosage form of Tamsulosin is tablet, dosage is 0.2mg, frequency is once daily and duration is 6 months. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men with low urinary tract symptoms aged between 40 and 80
- Estimated glomerular filtration rate < 60 or evidence of proteinuria
- Bladder outlet obstruction index > 40, Schäfer grade 2 or more, maximal flow rate lower than 10 cc/s or postvoid residual urine > 100cc
Key exclusion criteria (7 listed)
- Bladder outlet obstruction index less than 40, Schäfer grade 0 or 1, maximal flow rate higher than 10 ml/s and postvoid residual urine less than 100cc
- Want surgical procedure
- Evidence of prostate cancer or bladder cancer
- Major depressive disorder, Dementia, Parkinson's disease or neurological deficits
- History of pelvic irradiation
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 |
|---|---|---|
| TamsulosinAlso: Harnal D, TamsnalOnce Daily 0.2mg per oral for 6 months | Drug | Tamsulosin |
Primary outcome
Maximal flow rate
Time frame: 6 months
This parameter can be obtained from urodynamic study.
Maximal detrusor pressure
Time frame: 6 months
This parameter can be obtained from urodynamic study.
Bladder outlet obstruction index
Time frame: 6 months
This parameter can be obtained from urodynamic study.
schäfer grade
Time frame: 6 months
This parameter can be obtained from urodynamic study.
Compliance
Time frame: 6 months
This parameter can be obtained from urodynamic study.
2 secondary outcomes
Estimated glomerular filtration rate
Time frame: 6 months
Urinary protein to creatinine ratio
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
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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.
Seung-Ju Lee, MD, PhD study chair
The Catholic University of Korea
Dong Sup Lee, MD, PhD principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamsulosin in people with Chronic Kidney Failure and Prostatic Hyperplasia, run by The Catholic University of Korea at 1 site in South Korea.
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 17 Jan 2014. 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 South Korea. 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?
Contact Seung-Ju Lee, MD, PhD (82-31-249-8305, lee.seungju@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal flow rate (time frame: 6 months). The study lists 5 primary outcomes in all. 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 17 Jan 2014.