Renal ProtectionPhase 1NCT05946122
Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index
A Phase 1 study testing Atorvastatin 40 Mg Oral Tablet in people with Renal Protection, run by Minia University at 1 site in Egypt.
Trial summary
Offering renal protection in systemic inflammatory response syndrome by atorvastatin Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Renal Protection
- What is being tested?
- Atorvastatin 40 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2023to 30 Dec 2023
- Phase
- Phase 1
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ( male and female) with systemic inflammatory response ( total leucocytic count >12,000 mm3'. temperature >38 C, Heart rate >90 b/min and respiratory rate>20 cycle).
Who cannot join
- Hemodynamic instability
- Pre-admission chronic kidney disease.
- Intra-vascular coagulopathy
- Patients with myopathy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mina Maher Raouf
Minya, Minia University, 6115
mina M raouf, MBBCH, 02-01015752424, marlin27zarif@gmail.com
About this study
Offering renal protection in systemic inflammatory response syndrome by atorvastatin
- Conditions
- Renal Protection
- Being tested
- Atorvastatin 40 Mg Oral Tablet, placebo drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40 Mg Oral TabletDrug
oral atorvastatin for renal protection
placebo drugDrug
tablet resembles atorvastatin
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Not described Receives: Drug: placebo drug |
| Active ( Ator) group | Active comparator | Not described Receives: Drug: Atorvastatin 40 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
incidence or acute kidney injury
Measured: one week
Secondary outcomes (3)
renal resistive vascular index
renal resistive index
Measured: one week
APACHE score ( acute physiology and chronic health evaluation)
acute physiology and chronic health evaluation, values below 40 are considered normal while values between 41 and 71 are considered abnormal .
Measured: one week
length of ICU stay
days of ICU admission
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start30 May 2023
- Primary completion12 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ProtectionStudies of the same condition, open and under way.
- More trials run by Minia 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Maher, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946122
- Sponsor's protocol ID
- 343/ 8-2022
- Status last verified
- Jul 2023
- First submitted
- 27 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index
- ClinicalTrials.gov ID
- NCT05946122
- Acronym / sponsor ID
- 343/ 8-2022
- Conditions
- Renal Protection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 12 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 Jul 2023 (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.
Offering renal protection in systemic inflammatory response syndrome by atorvastatin
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: placebo drug |
| Active ( Ator) group | Active comparator | Drug: Atorvastatin 40 Mg Oral Tablet |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ( male and female) with systemic inflammatory response ( total leucocytic count >12,000 mm3'. temperature >38 C, Heart rate >90 b/min and respiratory rate>20 cycle).
Key exclusion criteria (4 listed)
- Hemodynamic instability
- Pre-admission chronic kidney disease.
- Intra-vascular coagulopathy
- Patients with myopathy.
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 |
|---|---|---|
| Atorvastatin 40 Mg Oral Tabletoral atorvastatin for renal protection | Drug | Active ( Ator) group |
| placebo drugtablet resembles atorvastatin | Drug | control group |
Primary outcome
Acute kidney injury
Time frame: one week
incidence or acute kidney injury
3 secondary outcomes
renal resistive vascular index
Time frame: one week
APACHE score ( acute physiology and chronic health evaluation)
Time frame: one week
length of ICU stay
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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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 Phase 1 study testing Atorvastatin 40 Mg Oral Tablet in people with Renal Protection, run by Minia 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 1 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Acute kidney injury (time frame: one week). 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 14 Jul 2023.