NephrotoxicityPhase 3NCT07668141
Colistin Nephrotoxicity and Role of Alpha Lipoic Acid
A Phase 3 study testing alpha lipoic acid drug (thioctic acid acid) in people with Nephrotoxicity, run by Helwan University at 2 sites in Egypt.
Trial summary
Nephrotoxicity is a great concern in patients receiving intravenous colistin and there is a disparity in the reported rates between previous studies. Several preclinical researches studied the effect of the antioxidants (e.g. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nephrotoxicity
- What is being tested?
- alpha lipoic acid drug (thioctic acid acid)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Jun 2026to 28 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who receive intravenous colistin and had positive cultures of multidrug resistant gram negative bacteria.
- Patients who receive colistin for at least 3 days during their treatment.
Who cannot join
- Patients who receive inhaled colistin.
- Patients who had AKI at baseline
- chronic kidney disease patients on regular hemodialysis.
- Renal transplant patients
- Concurrent use of other nephrotoxic drugs e.g. vancomycin, gentamicin, amikacin and amphotericin B.
- Concurrent use of other antioxidants e.g. vitamin C, vitamin E and N-acetyl cysteine.
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- Patients are not willing to participate in the study.
- Patients with any missed doses of colistin and or alpha-lipoic acid.
- Patients with incomplete medical data
- Pregnant or breastfeeding women.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
6th October Hospital-Dokki-General Authority for Health Insurance Organization
Giza
Mohamed Taher Mohy Eldien, Vascular surgery consultant, +201272228188, mtm84mohy@gmail.com
Al-Haram Hospital
Giza
Ghada Abdelwahab Ali, Nephrology consultant, +201022610334, Ghadaabdeleahab@gmail.com
About this study
Official title: Colistin Nephrotoxicity in Hospitalized Patients: The Role of Biomarkers in Guiding the Preventive Strategies
Nephrotoxicity is a great concern in patients receiving intravenous colistin and there is a disparity in the reported rates between previous studies. Several preclinical researches studied the effect of the antioxidants (e.g. L.carnitine, vitamin C, vitamin E, N-acetyl cysteine, and alpha lipoic acid) in reducing the risk of colistin-induced nephrotoxicity but there is a lack of clinical studies on human. Due to the paucity of studies that early predict colistin-induced nephrotoxicity using early acute kidney injury "AKI" biomarkers e.g. kidney injury molecule 1"KIM1" and the lack of human studies that evaluate the role of alpha lipoic acid in ameliorating colistin-induced nephrotoxicity, so this study will be conducted.
Read the detailed description
According to World Health Organization (WHO), multidrug resistant (MDR) pathogens (e.g. Extended-spectrum beta-lactamases (ESBL), Carbapenem Resistant Enterobacteriaceae (CRE)) are one of the major public threats that yearly cause several million deaths globally. In 2019, Egypt recorded 56,600 deaths linked to antimicrobial resistance (AMR), ranking 58th out of 204 countries for age-standardized mortality rates related to AMR. Regarding the North Africa and Middle East region, Egypt has the second highest mortality rate among 21 countries. The deaths from AMR in Egypt surpass those from diabetes, kidney diseases, transport injuries, chronic respiratory diseases, respiratory infections, tuberculosis, and neurological disorders. In 2021, WHO published the list of antibiotic-resistant pathogens especially the critical group of MDR bacteria includes Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacteriaceae, which cause severe infections in hospitalized patients. The resistance rate of carbapenem-resistant gram-negative bacteria (CR-GNB) is increasing over time. According to data from the chain antimicrobial resistance surveillance system, the resistance rate of carbapenem-resistant Klebsiella pneumoniae increased from 4.9% to 10.9% from 2013 to 2020. The resistance rates of carbapenem-resistant Acinetobacter baumannii and Enterobacteriaceae were 53.7% and 18.3%, respectively, in 2020.
Colistin is a polymyxin antibiotic first developed in 1947, fell out of favor due to its nephrotoxicity. With the rise of extensively drug-resistant Gram-negative bacteria, colistin has re-emerged as a last-resort treatment. However, its nephrotoxicity is considered as the main obstacle for using this valuable antibiotic. Colistin-induced nephrotoxicity has been reported in about 20-60% of treated patients. The mechanism of renal toxicity is through increased permeability of the renal tubular epithelium, increasing renal oxidative stress leading to cellular lysis and acute tubular necrosis. Nephrotoxicity incidence is influenced by many risk factors including dosage, and patient-related characteristics such as age, preexisting renal disease, diabetes, hypoalbuminemia, and other concomitant nephrotoxic compounds exposure.
AKI is usually diagnozed based on SCr and urine output. However, these markers are not specific and sensitive to GFR due to extra-renal factors, such as nutrition status, age, and muscle mass and fluid resuscitation. Serum creatinine is nonspecific to structural injury and has a nonlinear relationship with GFR, indicating that vast changes in GFR only signify a slight change in SCr. the changes in creatinine level lag behind the decreases in the GFR and can take up to 24-36 h to show a significant increase after obvious renal insult. Recognizing pharmacological interventions used to prevent or attenuate colistin-induced nephrotoxicity has gained special interest among healthcare professionals in recent years. Different clinical and preclinical studies were conducted to investigate the nephro-protective effect of some antioxidants e.g. melatonin, N-acetyl cysteine (NAC) and alpha lipoic acid (ALA) to prevent colistin nephrotoxicity. For example, ALA administration could reverse the effects of colistin-induced nephrotoxicity, owing to its antioxidant and anti-apoptotic effect as showed in a preclinical study on 2021.
Till now, there is no any published human study to evaluate the role of alpha lipoic acid in ameliorating colistin-induced nephrotoxicity. In addition the paucity of studies that early predict colistin-induced nephrotoxicity especially in Egypt which has a growing need for colistin therapy as it has the higher rates of antimicrobial resistance associated mortality in the North Africa and Middle East region.
- Conditions
- Nephrotoxicity
- Being tested
- alpha lipoic acid drug (thioctic acid acid)
- Keywords
- colistin, Alpa lipoic acid, kidney injury molecule-1, Nephrotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha lipoic acid drug (thioctic acid acid)Drug
Oral alpha-lipoic acid will be administered at the start of colistin therapy till the end of the colistin course by a dose of 600 mg every 8 hours to be taken 30 min before meals in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | this group receives only intravenous colistin therapy |
| alpha lipoic acid group | Active comparator | this group receives oral alpha lipoic acid in addition to intravenous colistin therapy Receives: Drug: alpha lipoic acid drug (thioctic acid acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary kidney injury molecule-1 (KIM-1)
Urinary KIM-1 will be measured at baseline and on Day 5 of treatment in patients receiving colistin alone or colistin plus alpha-lipoic acid.
Measured: Baseline to Day 5
Secondary outcomes (1)
Time to Development of Acute Kidney Injury
Time from randomization to the first documented occurrence of acute kidney injury during colistin therapy in the control group and the intervention group.
Measured: From randomization until the first occurrence of acute kidney injury, hospital discharge, death from any cause, or colistin discontinuation, whichever occurs first, assessed up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrotoxicityStudies 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
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Magdy El-sayed El-yamany, Helwan University
- Investigators
- Eman Magdy Elsayed Elyamany, Assistant lecturer, Principal investigator, Faculty of pharmacy-Helwan university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668141
- Sponsor's protocol ID
- 02H2025
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colistin Nephrotoxicity in Hospitalized Patients: The Role of Biomarkers in Guiding the Preventive Strategies
- ClinicalTrials.gov ID
- NCT07668141
- Acronym / sponsor ID
- 02H2025
- Conditions
- Nephrotoxicity
- Keywords
- colistin, Alpa lipoic acid, kidney injury molecule-1, Nephrotoxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 25 Jun 2026 (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.
Nephrotoxicity is a great concern in patients receiving intravenous colistin and there is a disparity in the reported rates between previous studies. Several preclinical researches studied the effect of the antioxidants (e.g. L.carnitine, vitamin C, vitamin E, N-acetyl cysteine, and alpha lipoic acid) in reducing the risk of colistin-induced nephrotoxicity but there is a lack of clinical studies on human. Due to the paucity of studies that early predict colistin-induced nephrotoxicity using early acute kidney injury "AKI" biomarkers e.g. kidney injury molecule 1"KIM1" and the lack of human studies that evaluate the role of alpha lipoic acid in ameliorating colistin-induced nephrotoxicity, so this study will be conducted.
Detailed description
According to World Health Organization (WHO), multidrug resistant (MDR) pathogens (e.g. Extended-spectrum beta-lactamases (ESBL), Carbapenem Resistant Enterobacteriaceae (CRE)) are one of the major public threats that yearly cause several million deaths globally. In 2019, Egypt recorded 56,600 deaths linked to antimicrobial resistance (AMR), ranking 58th out of 204 countries for age-standardized mortality rates related to AMR. Regarding the North Africa and Middle East region, Egypt has the second highest mortality rate among 21 countries. The deaths from AMR in Egypt surpass those from diabetes, kidney diseases, transport injuries, chronic respiratory diseases, respiratory infections, tuberculosis, and neurological disorders. In 2021, WHO published the list of antibiotic-resistant pathogens especially the critical group of MDR bacteria includes Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacteriaceae, which cause severe infections in hospitalized patients. The resistance rate of carbapenem-resistant gram-negative bacteria (CR-GNB) is increasing over time. According to data from the chain antimicrobial resistance surveillance system, the resistance rate of carbapenem-resistant Klebsiella pneumoniae increased from 4.9% to 10.9% from 2013 to 2020. The resistance rates of carbapenem-resistant Acinetobacter baumannii and Enterobacteriaceae were 53.7% and 18.3%, respectively, in 2020.
Colistin is a polymyxin antibiotic first developed in 1947, fell out of favor due to its nephrotoxicity. With the rise of extensively drug-resistant Gram-negative bacteria, colistin has re-emerged as a last-resort treatment. However, its nephrotoxicity is considered as the main obstacle for using this valuable antibiotic. Colistin-induced nephrotoxicity has been reported in about 20-60% of treated patients. The mechanism of renal toxicity is through increased permeability of the renal tubular epithelium, increasing renal oxidative stress leading to cellular lysis and acute tubular necrosis. Nephrotoxicity incidence is influenced by many risk factors including dosage, and patient-related characteristics such as age, preexisting renal disease, diabetes, hypoalbuminemia, and other concomitant nephrotoxic compounds exposure.
AKI is usually diagnozed based on SCr and urine output. However, these markers are not specific and sensitive to GFR due to extra-renal factors, such as nutrition status, age, and muscle mass and fluid resuscitation. Serum creatinine is nonspecific to structural injury and has a nonlinear relationship with GFR, indicating that vast changes in GFR only signify a slight change in SCr. the changes in creatinine level lag behind the decreases in the GFR and can take up to 24-36 h to show a significant increase after obvious renal insult. Recognizing pharmacological interventions used to prevent or attenuate colistin-induced nephrotoxicity has gained special interest among healthcare professionals in recent years. Different clinical and preclinical studies were conducted to investigate the nephro-protective effect of some antioxidants e.g. melatonin, N-acetyl cysteine (NAC) and alpha lipoic acid (ALA) to prevent colistin nephrotoxicity. For example, ALA administration could reverse the effects of colistin-induced nephrotoxicity, owing to its antioxidant and anti-apoptotic effect as showed in a preclinical study on 2021.
Till now, there is no any published human study to evaluate the role of alpha lipoic acid in ameliorating colistin-induced nephrotoxicity. In addition the paucity of studies that early predict colistin-induced nephrotoxicity especially in Egypt which has a growing need for colistin therapy as it has the higher rates of antimicrobial resistance associated mortality in the North Africa and Middle East region.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –this group receives only intravenous colistin therapy |
| alpha lipoic acid group | Active comparator | Drug: alpha lipoic acid drug (thioctic acid acid)this group receives oral alpha lipoic acid in addition to intravenous colistin therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients who receive intravenous colistin and had positive cultures of multidrug resistant gram negative bacteria.
- Patients who receive colistin for at least 3 days during their treatment.
Key exclusion criteria (10 listed)
- Patients who receive inhaled colistin.
- Patients who had AKI at baseline
- chronic kidney disease patients on regular hemodialysis.
- Renal transplant patients
- Concurrent use of other nephrotoxic drugs e.g. vancomycin, gentamicin, amikacin and amphotericin B.
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 |
|---|---|---|
| alpha lipoic acid drug (thioctic acid acid)Oral alpha-lipoic acid will be administered at the start of colistin therapy till the end of the colistin course by a dose of 600 mg every 8 hours to be taken 30 min before meals in the intervention group. | Drug | alpha lipoic acid group |
Primary outcome
Change in urinary kidney injury molecule-1 (KIM-1)
Time frame: Baseline to Day 5
Urinary KIM-1 will be measured at baseline and on Day 5 of treatment in patients receiving colistin alone or colistin plus alpha-lipoic acid.
1 secondary outcome
Time to Development of Acute Kidney Injury
Time frame: From randomization until the first occurrence of acute kidney injury, hospital discharge, death from any cause, or colistin discontinuation, whichever occurs first, assessed up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant confidentiality.
Related trials for Nephrotoxicity
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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.
Eman Magdy Elsayed Elyamany, Assistant lecturer principal investigator
Faculty of pharmacy-Helwan university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alpha lipoic acid drug (thioctic acid acid) in people with Nephrotoxicity, run by Helwan University at 2 sites 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 10 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Magy Elsayed Elyamany, Assistant lecturer (+201121051356, Iman.elyamany@pharm.capu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary kidney injury molecule-1 (KIM-1) (time frame: Baseline to Day 5). 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 25 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.