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RhabdomyolysisPhase 4NCT06491394

Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats

A Phase 4 study testing Lactoferrin, iron and MDA, TAC, and GSH in people with Rhabdomyolysis, run by Aswan University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study focuses on detecting the possible beneficial effect of Lactoferrin (Lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (RM) in rats and its relation to ferroptosis and AMPK/Nrf2/ HO-1 signalling pathway. The main questions it aims to answer are: 1. Is Lf administration 30 min. Read more about this study

Who is it for?
Ages 10 to 12 weeks, men only
Conditions the study is for
Rhabdomyolysis
What is being tested?
Lactoferrin, iron and MDA, TAC, and GSH
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteEgypt
Study dates
1 Nov 2024to 1 Apr 2025
Phase
Phase 4
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 10 to 12 weeks
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • • Twenty-four healthy male Wistar Albino rats weighing from 250 to 300 g

Who cannot join

  • No exclusion criteria as this study is used to detect effects of drugs on experimental rats.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Medicine

    Aswān, Aswan Governorate, 81528

Other trials in Egypt

About this study

Official title: Effect of Lactoferrin Administration on Rhabdomyolysis-induced Heart and Kidney Injury in Rats

This study focuses on detecting the possible beneficial effect of Lactoferrin (Lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (RM) in rats and its relation to ferroptosis and AMPK/Nrf2/ HO-1 signalling pathway. The main questions it aims to answer are:

  1. Is Lf administration 30 min. before or after RM induction in rats beneficial to kidneys and heart?
  2. When administered to glycerol-induced rats, does Lf act by upregulating the AMPK/Nrf2/ HO-1 signalling pathway and inhibiting ferroptosis?
Conditions
Rhabdomyolysis
Being tested
Lactoferrin, iron, MDA, TAC, and GSH, Nrf2, AMPK
Medical subject headings
Rhabdomyolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LactoferrinDrug

    an iron-binding protein

  • ironDiagnostic test

    Iron in kidney and heart tissues

  • MDA, TAC, and GSHDiagnostic test

    Also called Malondialdehyde, Total antioxidant, and glutathione

    Oxidative stress levels in kidney and heart tissues

  • Nrf2Diagnostic test

    Also called Nuclear factor erythroid 2-related factor 2

    Nrf2 expression in kidney and heart tissues

  • AMPKDiagnostic test

    Also called Adenosine monophosphate-activated protein kinase

    AMPK levels in heart and kidney tissues

  • HO-1Diagnostic test

    Also called heme oxygenase-1

    HO-1 levels in kidney and heart tissues

  • glycerinDrug

    Also called GLY

    GLY intramuscular injection for rhabdomyolysis induction

Study groups in NCT06491394
Study groupRoleWhat they receive
ControlSham comparatorNormal saline will be administered once to rats intramuscularly (10 mL/kg).
Receives: Diagnostic Test: iron; Diagnostic Test: MDA, TAC, and GSH; Diagnostic Test: Nrf2; Diagnostic Test: AMPK; Diagnostic Test: HO-1
RMActive comparatorA single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.
Receives: Diagnostic Test: iron; Diagnostic Test: MDA, TAC, and GSH; Diagnostic Test: Nrf2; Diagnostic Test: AMPK; Diagnostic Test: HO-1; Drug: glycerin
Lf-RMActive comparatorA single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction
Receives: Drug: Lactoferrin; Diagnostic Test: iron; Diagnostic Test: MDA, TAC, and GSH; Diagnostic Test: Nrf2; Diagnostic Test: AMPK; Diagnostic Test: HO-1; Drug: glycerin
RM-LfActive comparatorA single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.
Receives: Drug: Lactoferrin; Diagnostic Test: iron; Diagnostic Test: MDA, TAC, and GSH; Diagnostic Test: Nrf2; Diagnostic Test: AMPK; Diagnostic Test: HO-1; Drug: glycerin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nrf2 expression

    Nrf2 expression in heart and kidney tissues

    Measured: 2 months

  2. AMPK levels

    AMPK levels in kidney and heart tissue homogenate

    Measured: 2 months

  3. HO-1 levels

    HO-1 levels in kidney and heart tissue homogenate

    Measured: 2 months

Secondary outcomes (4)

  1. iron levels

    Iron levels in heart and kidney tissue homogenate

    Measured: 2 months

  2. MDA levels

    MDA levels in heart and kidney tissue homogenate

    Measured: 2 months

  3. TAC levels

    TAC levels in heart and kidney tissue homogenate

    Measured: 2 months

  4. GSH levels

    GSH levels in heart and kidney tissue homogenate

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2024
  2. Study start1 Nov 2024
  3. Primary completion1 Mar 2025
  4. Study completion1 Apr 2025

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06491394
Sponsor's protocol ID
Lactoferrin in rhabdomyolysis
Status last verified
Jul 2025
First submitted
1 Jul 2024
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lactoferrin, iron and MDA, TAC, and GSH in people with Rhabdomyolysis, run by Aswan University Hospital 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 1 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 4 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Nrf2 expression (time frame: 2 months). The study lists 3 primary outcomes in all. 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 NCT06491394.

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 4 Jul 2025.

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