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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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)
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.
Show all 10Show fewer
  • 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.

Eman Magy Elsayed Elyamany, Assistant lecturer contact

+201121051356

Iman.elyamany@pharm.capu.edu.eg

Mahmoud Ibrahim Mostafa, Lecturer contact

+201006605563

mahmoud.ibrahim@pharm.capu.edu.eg

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

Other trials in Egypt

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 groups in NCT07668141
Study groupRoleWhat they receive
Control groupNo interventionthis group receives only intravenous colistin therapy
alpha lipoic acid groupActive comparatorthis 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.

  1. 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)
  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.

  1. First posted25 Jun 2026
  2. Study start30 Jun 2026 (estimated)
  3. Primary completion30 Jan 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

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)
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.

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.

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