Acute Kidney InjuryPhase 2NCT03329443
The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography
A Phase 2 study testing Spironolactone in people with Acute Kidney Injury and IHD, run by Alhasan Mujtaba Abdul-Wahid at 1 site in Iraq.
Trial summary
an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, IHD, Contrast-induced Nephropathy
- What is being tested?
- Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 490 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2017to 4 Sep 2018
- Phase
- Phase 2
- 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
- patients admitted to angiography unit
- over 18
- informed consent
Who cannot join
- acute renal failure before 7 days
- spironolactone contraindications
- hyperkalemia (S.K. >5.5 mEq/L)
- documented tumor
- actively taking NSAIDs, Ciclosporin, Cisplatin,
Trial locations and contacts
1 site in 1 country.
About this study
an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography
- Conditions
- Acute Kidney Injury, IHD, Contrast-induced Nephropathy
- Being tested
- Spironolactone, Placebo Oral Tablet
- Keywords
- spironolactone
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Also called Active group
each patient will receive 200 mg of spironolactone as per his/her angiography premedications
Placebo Oral TabletDrug
Also called Control group
Each patient will receive a placebo tablet as per his/her angiography premedications
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: Placebo Oral Tablet |
| Spironolactone | Active comparator | Not described Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury by K-DIGO guidelines
an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline
Measured: 48-72 hrs
Secondary outcomes (1)
acute kidney injury by NGAL
assessment of serum NGAL at admission and after 6 hrs to detect possible AKI in selected patients
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start1 Sep 2017
- Primary completion1 Sep 2018
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alhasan Mujtaba Abdul-Wahid
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health-Basra Health Directorate-Al-Sader Teaching Hospital
- Responsible party
- Sponsor-investigator, Alhasan Mujtaba Abdul-Wahid, University of Baghdad
- Investigators
- Alhasan Mujtaba, BCPS, Principal investigator, Baghdad University/College of Pharmacy/Department of Clinical PharmacyMohammed A Taher, Ph.D., Study chair, Baghdad University/College of Pharmacy/Department of BiochemistryMazin A Hazzaa', Ph.D., Study director, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. CardiologistHassan M Al Rubaye, Ph.D, Study director, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. CardiologistAssad H Kata, Ph.D, Study director, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. CardiologistHayder K Abdullkreem, M.Sc, Study director, Head of the clinical laboratory department/ Al-Sader teaching hopitalHamid A Abdulsada, Ph.D, Study director, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. CardiologistAbdul Ameer A Abdul Hameed, PH.D, Study director, Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329443
- Sponsor's protocol ID
- CT00964
- Status last verified
- Sep 2018
- First submitted
- 30 Oct 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mujtaba A, Taher MA, Hazza MA, Al-Rubaye HM, Kata AH, AbdulWahab H, AbdulBari A, AlRubay HK. The Effect of Spironolactone on the Incidence of Contrast-Induced Nephropathy in Patients Undergoing Cardiac Catheterization: Study Design and Rationale. Cardiol Ther. 2018 Jun;7(1):101-106. doi: 10.1007/s40119-018-0112-3. Epub 2018 May 21.
PubMed 29785539
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Spironolactone on Acute Kidney Injury in Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT03329443
- Acronym / sponsor ID
- CT00964
- Conditions
- Acute Kidney Injury, IHD, Contrast-induced Nephropathy
- Keywords
- spironolactone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Alhasan Mujtaba Abdul-WahidUniversity, hospital or other
- Collaborators
- Ministry of Health-Basra Health Directorate-Al-Sader Teaching Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 6 Nov 2017 (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.
an interventional study to measure the possible effects of spironolactone ( an aldosterone antagonist) on the incidence of acute kidney injury after coronary angiography
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placebo Oral Tablet |
| Spironolactone | Active comparator | Drug: Spironolactone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients admitted to angiography unit
- over 18
- informed consent
Key exclusion criteria (5 listed)
- acute renal failure before 7 days
- spironolactone contraindications
- hyperkalemia (S.K. >5.5 mEq/L)
- documented tumor
- actively taking NSAIDs, Ciclosporin, Cisplatin,
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 |
|---|---|---|
| SpironolactoneAlso: Active groupeach patient will receive 200 mg of spironolactone as per his/her angiography premedications | Drug | Spironolactone |
| Placebo Oral TabletAlso: Control groupEach patient will receive a placebo tablet as per his/her angiography premedications | Drug | placebo |
Primary outcome
Acute kidney injury by K-DIGO guidelines
Time frame: 48-72 hrs
an absolute elevation of serum creatinine of 0.5mg/dl or 25% above baseline
1 secondary outcome
acute kidney injury by NGAL
Time frame: 6 hours
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 10 Sep 2018.
- Derived from this study: PubMed 29785539Mujtaba A, Taher MA, Hazza MA, Al-Rubaye HM, Kata AH, AbdulWahab H, AbdulBari A, AlRubay HK. The Effect of Spironolactone on the Incidence of Contrast-Induced Nephropathy in Patients Undergoing Cardiac Catheterization: Study Design and Rationale. Cardiol Ther. 2018 Jun;7(1):101-106. doi: 10.1007/s40119-018-0112-3. Epub 2018 May 21.
- Individual participant dataSharing planned: Undecided
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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.
Alhasan Mujtaba, BCPS principal investigator
Baghdad University/College of Pharmacy/Department of Clinical Pharmacy
Mohammed A Taher, Ph.D. study chair
Baghdad University/College of Pharmacy/Department of Biochemistry
Mazin A Hazzaa', Ph.D. study director
Al-Sader teaching Hospital/Basra Cardiac Center/M.D. Cardiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolactone in people with Acute Kidney Injury and IHD, run by Alhasan Mujtaba Abdul-Wahid at 1 site in Iraq.
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 5 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 10 Sep 2018. 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 Iraq. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Acute kidney injury by K-DIGO guidelines (time frame: 48-72 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03329443, which also lists 1 linked publication.
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 10 Sep 2018.