Acute Kidney InjuryPhase 3NCT05613361
The Effect of Curcumin Against Colistin-induced Nephrotoxicity
A Phase 3 study testing Colistin and Curcumin in people with Acute Kidney Injury and Drug-Induced Nephropathy, run by October 6 University at 1 site in Egypt.
Trial summary
The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Drug-Induced Nephropathy
- What is being tested?
- Colistin and Curcumin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Oct 2024
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All critically ill adult patients (18-65 years old) who are infected by MDR Gram-negative bacteria and require intravenous colistin therapy
Who cannot join
- Patients receiving intravenous colistin therapy for < 72 hours.
- Patients receiving renal replacement therapy (RRT).
- Patients with diseases that may contribute to renal impairment such as systemic lupus erythematosus, acute myocardial infarction, cancer, HIV infection, glucose-6-phosphate-dehydrogenase deficiency, or urinary tract stone.
- Pregnancy or breastfeeding.
- Known allergy to the study medications.
- Patients with chronic kidney diseases (creatinine clearance < 60 mg/dL).
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- Elevated total liver enzymes (AST, and ALT) three times above the upper limit of normal.
- Patients with acute decompensated heart failure signs and symptoms requiring intravenous loop diuretics and/or intravenous inotropes and/or ACE inhibitors.
- Uncontrolled diabetes (Glycosylated hemoglobin (Hb A1C) >8%).
- Hypotensive patients defined as decrease in blood pressure less than 90/60 mm Hg.
- Recent use of vitamins with antioxidant properties such as beta carotene, vitamin E, vitamin C, selenium, or N-acetylcysteine or any other medications known to have nephroprotective activities.
- Patients receiving other nephrotoxic drugs at enrollment (e.g., aminoglycosides, vancomycin, or amphotericin B) or administration of contrast medium within 7 days.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals
Cairo, 1133
Alaa M Hammad, 01000675555, alaa.hammad.ph@o6u.edu.eg
About this study
The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin.
Read the detailed description
The study will investigate the possible nephroprotective effect of curcumin when added to patients infected by MDR Gram-negative bacteria and require intravenous colistin therapy, curcumin will be given concurrently with colistin and discontinued at the same time as Colistin.
- Conditions
- Acute Kidney Injury, Drug-Induced Nephropathy
- Being tested
- Colistin, Curcumin
- 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.
ColistinDrug
added for infection with multi drug resistant bacteria
CurcuminDrug
added for the possible nephroprotective effect
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours. Receives: Drug: Colistin |
| Group 2 | Active comparator | patients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours and curcumin will be administered as orally or through nasogastric tube at a dose of 2 capsules every 6 hours (1 gm/6 hour) Receives: Drug: Colistin; Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute kidney injury
colistin induced nephrotoxicity (CIN) is defined as increase of serum creatinine by 0.3 mg/dL 48 hours after colistin administration
Measured: Baseline to hospital discharge, an average of 14 days.
Secondary outcomes (4)
The incidence of acute tubular necrosis (ATN)
will be evaluated by fractional excreted sodium (FENa)
Measured: Baseline to hospital discharge, an average of 14 days.
The difference between the levels of urinary NGAL
Measured: Baseline to hospital discharge, an average of 14 days.
Mortality rate
Measured: Baseline to 30 days post discharge
Total length of ICU and hospital stays.
Measured: Baseline to hospital discharge, an average of 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Jan 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Alaa Mohammed Hammad, October 6 University
- Investigators
- Nirmeen A. Sabry, Principal investigator, Professor of Clinical Pharmacy Faculty of Pharmacy Cairo UniversityMaggie M. Abbassi, Principal investigator, Professor of Clinical Pharmacy Faculty of Pharmacy Cairo UniversityRania El-Husseiny, Principal investigator, Professor of Critical Care Medicine, Faculty of Medicine Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613361
- Sponsor's protocol ID
- curcumin in nephrotoxicity
- Status last verified
- Oct 2023
- First submitted
- 1 Nov 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Curcumin Against Colistin-induced Nephrotoxicity
- ClinicalTrials.gov ID
- NCT05613361
- Acronym / sponsor ID
- curcumin in nephrotoxicity
- Conditions
- Acute Kidney Injury, Drug-Induced Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 14 Nov 2022 (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.
The goal of this study is to investigate the possible nephroprotective effect of curcumin in critically ill patients receiving colistin.
Detailed description
The study will investigate the possible nephroprotective effect of curcumin when added to patients infected by MDR Gram-negative bacteria and require intravenous colistin therapy, curcumin will be given concurrently with colistin and discontinued at the same time as Colistin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Colistinpatients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours. |
| Group 2 | Active comparator | Drug: Colistin, Drug: Curcuminpatients in this group will receive loading dose of colistin intravenously of 9 MIU followed by maintenance doses of 4.5 MIU given every 12 hours and curcumin will be administered as orally or through nasogastric tube at a dose of 2 capsules every 6 hours (1 gm/6 hour) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All critically ill adult patients (18-65 years old) who are infected by MDR Gram-negative bacteria and require intravenous colistin therapy
Key exclusion criteria (12 listed)
- Patients receiving intravenous colistin therapy for < 72 hours.
- Patients receiving renal replacement therapy (RRT).
- Patients with diseases that may contribute to renal impairment such as systemic lupus erythematosus, acute myocardial infarction, cancer, HIV infection, glucose-6-phosphate-dehydrogenase deficiency, or urinary tract stone.
- Pregnancy or breastfeeding.
- Known allergy to the study medications.
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 |
|---|---|---|
| Colistinadded for infection with multi drug resistant bacteria | Drug | Group 1, Group 2 |
| Curcuminadded for the possible nephroprotective effect | Drug | Group 2 |
Primary outcome
The incidence of acute kidney injury
Time frame: Baseline to hospital discharge, an average of 14 days.
colistin induced nephrotoxicity (CIN) is defined as increase of serum creatinine by 0.3 mg/dL 48 hours after colistin administration
4 secondary outcomes
The incidence of acute tubular necrosis (ATN)
Time frame: Baseline to hospital discharge, an average of 14 days.
The difference between the levels of urinary NGAL
Time frame: Baseline to hospital discharge, an average of 14 days.
Mortality rate
Time frame: Baseline to 30 days post discharge
Total length of ICU and hospital stays.
Time frame: Baseline to hospital discharge, an average of 14 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Yes
Related trials for Acute Kidney Injury
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Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
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Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Nirmeen A. Sabry principal investigator
Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
Maggie M. Abbassi principal investigator
Professor of Clinical Pharmacy Faculty of Pharmacy Cairo University
Rania El-Husseiny principal investigator
Professor of Critical Care Medicine, Faculty of Medicine Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colistin and Curcumin in people with Acute Kidney Injury and Drug-Induced Nephropathy, run by October 6 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 12 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 31 Oct 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Alaa M. Hammad (01000675555, alaa.hammad.ph@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of acute kidney injury (time frame: Baseline to hospital discharge, an average of 14 days.). 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 31 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.