Losartan Adverse ReactionNCT04278495
The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney
A study testing Cozaar (Losartan Potassium 25mg) in people with Losartan Adverse Reaction and Uropathy, run by Mansoura University at 1 site in Egypt.
Trial summary
Previous experimental studies concluded that angiotensin receptor blockers can ameliorate the harmful inflammatory and histological changes after relief of obstruction. Nevertheless, these witnessed effects have not been yet translated into the clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Losartan Adverse Reaction, Uropathy, Uropathy Obstructive
- What is being tested?
- Cozaar (Losartan Potassium 25mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2014to 1 Dec 2018
- 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
- anuric and oliguric patients
- calculuar ureteral obstruction
Who cannot join
- anomalous kidney
- bilateral obstructed kidney
- history of recent use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors
- ASA score of >3
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and nephrology center
Al Mansurah, Outside U.S./Canada, 35516
About this study
Official title: The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney: A Double Blind Randomized Placebo-controlled Trial
Previous experimental studies concluded that angiotensin receptor blockers can ameliorate the harmful inflammatory and histological changes after relief of obstruction. Nevertheless, these witnessed effects have not been yet translated into the clinical practice.
- Conditions
- Losartan Adverse Reaction, Uropathy, Uropathy Obstructive
- Being tested
- Cozaar (Losartan Potassium 25mg), Placebo
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cozaar (Losartan Potassium 25mg)Drug
Also called Cozaar
Cozaar (Losartan Potassium 25mg)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Losartan | Active comparator | to receive the medication Cozaar (Losartan Potassium 25mg "Merck Sharp \& Dohme-UK"), Receives: Drug: Cozaar (Losartan Potassium 25mg) |
| Placebo | Placebo comparator | to receive either placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renographic glomerular filtration rate of the affected kidney.
assessed by radioisotope renography using 99mTc-mercaptoacetyltriglycine (99mTc-MAG3) in ml/min
Measured: 3 months
Secondary outcomes (1)
Serum creatinine change
assessed by serum creatnine in mg/dl
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Sep 2014
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Losartan Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed Shokier, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278495
- Sponsor's protocol ID
- LOSARTAN.OBST.UROPATHY
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Losartan on the Recoverability of Renal Function in Anuric and Oliguric Patients With Unilateral Obstructed Kidney: A Double Blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04278495
- Acronym / sponsor ID
- LOSARTAN.OBST.UROPATHY
- Conditions
- Losartan Adverse Reaction, Uropathy, Uropathy Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 20 Feb 2020 (actual)
- 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.
Previous experimental studies concluded that angiotensin receptor blockers can ameliorate the harmful inflammatory and histological changes after relief of obstruction. Nevertheless, these witnessed effects have not been yet translated into the clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Losartan | Active comparator | Drug: Cozaar (Losartan Potassium 25mg)to receive the medication Cozaar (Losartan Potassium 25mg "Merck Sharp \& Dohme-UK"), |
| Placebo | Placebo comparator | Drug: Placeboto receive either placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- anuric and oliguric patients
- calculuar ureteral obstruction
Key exclusion criteria (4 listed)
- anomalous kidney
- bilateral obstructed kidney
- history of recent use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors
- ASA score of >3
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 |
|---|---|---|
| Cozaar (Losartan Potassium 25mg)Also: CozaarCozaar (Losartan Potassium 25mg) | Drug | Losartan |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Renographic glomerular filtration rate of the affected kidney.
Time frame: 3 months
assessed by radioisotope renography using 99mTc-mercaptoacetyltriglycine (99mTc-MAG3) in ml/min
1 secondary outcome
Serum creatinine change
Time frame: 3 months
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 20 Feb 2020.
- Individual participant dataSharing planned: No
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.
Ahmed Shokier study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cozaar (Losartan Potassium 25mg) in people with Losartan Adverse Reaction and Uropathy, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 4 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 20 Feb 2020. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
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?
Renographic glomerular filtration rate of the affected kidney. (time frame: 3 months). 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 20 Feb 2020.