NephrotoxicityPhase 2LCNCT07108777
L-Carnitine Protective Effect in Nephrotoxicity
A Phase 2 study testing L-Carnitine Tartrate in people with Nephrotoxicity, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to assess the possible reno-protective effect of L-carnitine against cisplatin-induced nephrotoxicity in patients receiving cisplatin-based chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nephrotoxicity
- What is being tested?
- L-Carnitine Tartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to 1 Nov 2026
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients.
- Newly diagnosed patients with cancer and with an indication for cisplatin - based chemotherapy.
- Age between 18 and 75 years.
- No serious cardiopulmonary comorbidity which could impair involvement in the study.
- Creatinine clearance value above 50 mL/min/1.73 m².
- Patients who will scheduled to receive at least 3 cycles of cisplatin.
- Patients with no previous renal diseases (including acute nephropathy, acute and chronic renal failure).
Who cannot join
- Pregnancy or lactation.
- Metastasis to the central nervous system.
- Psychiatric disorders.
- Prior treatment with platinum derivatives.
- Hypersensitivity to cisplatin, carboplatin or other platinum derivatives.
- Patients with active infection or any symptoms of sepsis.
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- Acute renal failure or renal surgery within the last 3 months.
- Patients unfit for cisplatin (patients with impaired renal function, sensorineural hearing loss and cardiomyopathy).
- Patients with known history or current treatment with nephrotoxic agents.
- Taking other antioxidant supplements such as Vitamins C and E.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Fatma M Eweda contact
Egypt1 site, 1 recruiting
- Recruiting
Menoufia Clinical Oncology Department, Menoufia University.
Shibīn al Kawm
Menoufia Clinical Oncology Department, Menoufia University, M
About this study
Official title: Clinical Study to Evaluate the Possible Protective Effect of L-Carnitine Against Cisplatin-Induced Nephrotoxicity
The goal of this clinical trial is to assess the possible reno-protective effect of L-carnitine against cisplatin-induced nephrotoxicity in patients receiving cisplatin-based chemotherapy. The main question it aims to answer is:
Does L-carnitine have the ability to protect the kidney against cisplatin-induced nephrotoxicity?
Read the detailed description
Cisplatin is one of the most effective chemotherapeutic agents that has been used for more than 50 years for a different solid Tumers. Nevertheless, its administration is associated with toxicity, including nephrotoxicity which can affects 25-35% of treated patients. Cisplatin nephrotoxicity mainly explained by accumulation in the renal tubules mostly in the proximal and distal tubules where it inhibits and alters the expression pattern of several membrane transporters and water channels and inhibits mitochondrial function and ATP production, thus generating oxidative stress. Cisplatin nephrotoxicity is also associated with an inflammatory response that plays a significant role in this event. Tumor necrosis factor alpha (TNF- α) is a pleiotropic pro-inflammatory cytokine that signals via TNFRSF1A and TNFRSF1B to activate nuclear factor kappa B (NF-κB) or Mitogen-activated protein kinase (MAPK), eventually leading to cytokine production and/or death signaling. L-carnitine owing to its antioxidant and anti-inflammatory properties has been used as a candidate for nephroprotection against drug induced nephrotoxicity (DIN). L-carnitine significantly ameliorates DIN in animal studies especially against cisplatin-induced renal damage. Inhibition of reactive oxygen species generation, lipid peroxidation, matrix remodeling and apoptosis, anti-inflammatory properties and improvement in carnitine deficiency has been suggested as probable nephroprotective mechanisms of L-carnitine.
- Conditions
- Nephrotoxicity
- Being tested
- L-Carnitine Tartrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Carnitine TartrateDrug
Also called L-Carnitine, Levocarnitine, carnitine
L-carnitine 350 mg three times daily by oral.
PlaceboDrug
Also called Matching placebo, inactive control
placebo tablet three times daily by oral.
| Study group | Role | What they receive |
|---|---|---|
| L-carnitine group | Active comparator | This group will receive the standard chemotherapy protocol (cisplatin -based chemotherapy) plus L-carnitine 350 mg (L-carnitine®) three times daily by oral. Receives: Drug: L-Carnitine Tartrate |
| Placebo group | Placebo comparator | This group will receive the standard chemotherapy protocol (cisplatin -based chemotherapy) plus placebo tablets with the same criteria of the intervention drug and the same dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum creatinine and creatinine clearance
serum creatinine average ranges are 0.7 to 1.2 (mg/dL) for males and 0.5 to 1.0 for females.
Measured: Baseline (before chemotherapy cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start10 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Mamdouh Elsayed Eweda, Tanta University
- Investigators
- Fatma M Eweda, Master, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108777
- Sponsor's protocol ID
- ONCO21
- Acronym
- LC
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Protective Effect of L-Carnitine Against Cisplatin-Induced Nephrotoxicity
- ClinicalTrials.gov ID
- NCT07108777
- Acronym / sponsor ID
- LC / ONCO21
- Conditions
- Nephrotoxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 Aug 2025 (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 clinical trial is to assess the possible reno-protective effect of L-carnitine against cisplatin-induced nephrotoxicity in patients receiving cisplatin-based chemotherapy. The main question it aims to answer is:
Does L-carnitine have the ability to protect the kidney against cisplatin-induced nephrotoxicity?
Detailed description
Cisplatin is one of the most effective chemotherapeutic agents that has been used for more than 50 years for a different solid Tumers. Nevertheless, its administration is associated with toxicity, including nephrotoxicity which can affects 25-35% of treated patients. Cisplatin nephrotoxicity mainly explained by accumulation in the renal tubules mostly in the proximal and distal tubules where it inhibits and alters the expression pattern of several membrane transporters and water channels and inhibits mitochondrial function and ATP production, thus generating oxidative stress. Cisplatin nephrotoxicity is also associated with an inflammatory response that plays a significant role in this event. Tumor necrosis factor alpha (TNF- α) is a pleiotropic pro-inflammatory cytokine that signals via TNFRSF1A and TNFRSF1B to activate nuclear factor kappa B (NF-κB) or Mitogen-activated protein kinase (MAPK), eventually leading to cytokine production and/or death signaling. L-carnitine owing to its antioxidant and anti-inflammatory properties has been used as a candidate for nephroprotection against drug induced nephrotoxicity (DIN). L-carnitine significantly ameliorates DIN in animal studies especially against cisplatin-induced renal damage. Inhibition of reactive oxygen species generation, lipid peroxidation, matrix remodeling and apoptosis, anti-inflammatory properties and improvement in carnitine deficiency has been suggested as probable nephroprotective mechanisms of L-carnitine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-carnitine group | Active comparator | Drug: L-Carnitine TartrateThis group will receive the standard chemotherapy protocol (cisplatin -based chemotherapy) plus L-carnitine 350 mg (L-carnitine®) three times daily by oral. |
| Placebo group | Placebo comparator | Drug: PlaceboThis group will receive the standard chemotherapy protocol (cisplatin -based chemotherapy) plus placebo tablets with the same criteria of the intervention drug and the same dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients.
- Newly diagnosed patients with cancer and with an indication for cisplatin - based chemotherapy.
- Age between 18 and 75 years.
- No serious cardiopulmonary comorbidity which could impair involvement in the study.
- Creatinine clearance value above 50 mL/min/1.73 m².
Key exclusion criteria (10 listed)
- Pregnancy or lactation.
- Metastasis to the central nervous system.
- Psychiatric disorders.
- Prior treatment with platinum derivatives.
- Hypersensitivity to cisplatin, carboplatin or other platinum derivatives.
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 |
|---|---|---|
| L-Carnitine TartrateAlso: L-Carnitine, Levocarnitine, carnitineL-carnitine 350 mg three times daily by oral. | Drug | L-carnitine group |
| PlaceboAlso: Matching placebo, inactive controlplacebo tablet three times daily by oral. | Drug | Placebo group |
Primary outcome
change in serum creatinine and creatinine clearance
Time frame: Baseline (before chemotherapy cycles)
serum creatinine average ranges are 0.7 to 1.2 (mg/dL) for males and 0.5 to 1.0 for females.
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 12 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Fatma M Eweda contact
Fatma M Eweda, Master principal investigator
Tanta University
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 L-Carnitine Tartrate in people with Nephrotoxicity, run by Tanta 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 7 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. 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 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?
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 Fatma M Eweda, Master (+201017045245, fatma.mamdouh7376@phrm.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in serum creatinine and creatinine clearance (time frame: Baseline (before chemotherapy cycles)). 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 12 Aug 2025.