NephrotoxicityNCT07873372
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
A study testing Rutin + Ascorbic Acid (RUTA C60®) and Ascorbic Acid (C-Retard®) in people with Nephrotoxicity and Acute Kidney Injuries, run by Ain Shams University at 1 site in Egypt.
Trial summary
Background: Vancomycin, a key antibiotic for MRSA infections, frequently causes nephrotoxicity (kidney damage) via oxidative stress, especially at the higher doses and longer durations now recommended. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nephrotoxicity, Acute Kidney Injuries
- What is being tested?
- Rutin + Ascorbic Acid (RUTA C60®) and Ascorbic Acid (C-Retard®)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 30 Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients admitted to different departments of the hospital
- Both genders, aged ≥18 years
- Susceptibility to gram-positive infection (MRSA) requiring vancomycin treatment for at least 7 days
- Not receiving any concurrent antioxidant treatment (e.g., vitamin E)
- Free of proteinuria and/or hematuria
- No prior history of acute kidney injury (AKI)
Who cannot join
- Known allergy to vancomycin, ascorbic acid, or rutin
- Pregnant or lactating females
- Baseline serum creatinine ≥2 mg/dL
- Receiving other nephrotoxic drugs at time of initiating vancomycin (e.g., aminoglycosides, colistin, amphotericin B, tacrolimus, cisplatin, or calcineurin inhibitors)
- Urinary tract stones
- Expected to undergo contrast medium administration within 7 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Rutin and Ascorbic Acid in Reducing The Incidence of Vancomycin Indueced Nephrotoxicity in Adult Patients
Background: Vancomycin, a key antibiotic for MRSA infections, frequently causes nephrotoxicity (kidney damage) via oxidative stress, especially at the higher doses and longer durations now recommended. Antioxidants like rutin and ascorbic acid (vitamin C) have shown promise in reducing this toxicity in preclinical and limited human studies, but no trial has tested them together.
Aim: Evaluate whether combined rutin + ascorbic acid supplementation reduces the incidence of vancomycin-induced nephrotoxicity (VAN) in adult patients, compared to ascorbic acid alone and a control group.
Read more
Design: Prospective, open-label, randomized controlled, three-arm clinical trial; 120 adult patients recruited from Internal Medicine departments at Ain Shams University Hospital.
Population: Adults (≥18) receiving vancomycin for ≥7 days for MRSA infections, without prior kidney injury, proteinuria/hematuria, or other antioxidant/nephrotoxic drug use.
Outcomes:
Primary: Changes in serum creatinine, NGAL, BUN, creatinine clearance, BUN/creatinine ratio Secondary: Serum potassium/sodium, CRP, total leukocyte count, procalcitonin
Read the detailed description
Background \& Rationale Vancomycin is a key antibiotic against MRSA but causes nephrotoxicity in 5-25% of patients (up to 35% with concurrent aminoglycosides), largely via oxidative stress and reactive oxygen species that trigger renal cell apoptosis.
Risk rises with newer high-dose regimens (trough 15-20 mg/L), treatment >5 days, obesity, intermittent infusion, and co-administration with other nephrotoxins (e.g., piperacillin/tazobactam, flucloxacillin).
Antioxidants (N-acetylcysteine, vitamin E) have shown benefit; ascorbic acid and rutin individually have antioxidant/anti-inflammatory effects supported by prior human and animal studies, but no trial has tested the rutin + vitamin C combination specifically for preventing vancomycin nephrotoxicity - this is the gap the study addresses.
Aim of the study:
Evaluate whether rutin + ascorbic acid supplementation reduces vancomycin-induced nephrotoxicity (VAN) versus ascorbic acid alone and versus control.
Study Design:
Prospective, open-label, randomized controlled, three-arm trial Setting: Internal Medicine departments, Ain Shams University Hospital Sample size: 120 patients (40/arm), calculated via G*Power (effect size 0.3, α=0.05, power 80%, adjusted for dropout)
Groups:
Group 1 (Intervention) Vancomycin + Rutin 60mg/Vitamin C 160mg (RUTA C60®), 2 tablets TID, 30 min pre-dose
Group 2 (Intervention) Vancomycin + Vitamin C 500mg (C-Retard®), 1 capsule BID, 30 min pre-dose
Group 3 (control) Vancomycin alone Randomization: Computer-generated block randomization (block size 6); allocation concealed via sequentially numbered, opaque, sealed envelopes (SNOSE).
Eligibility Criteria:
Include: Adults ≥18, MRSA infection needing vancomycin ≥7 days, no concurrent antioxidants, no proteinuria/hematuria/prior AKI Exclude: Drug allergies, pregnancy/lactation, baseline S.cr ≥2mg/dL, concurrent nephrotoxins, urinary stones, upcoming contrast media exposure
Outcomes:
Primary: Serum creatinine, plasma NGAL, BUN, creatinine clearance (Cockcroft-Gault), BUN/creatinine ratio Secondary: Serum K⁺/Na⁺, CRP, total leukocyte count, procalcitonin
- Conditions
- Nephrotoxicity, Acute Kidney Injuries
- Being tested
- Rutin + Ascorbic Acid (RUTA C60®), Ascorbic Acid (C-Retard®)
- Keywords
- Vancomycin, Rutin, Ascorbic Acid, Serum Creatinine, Oxidative Stress, NGAL, Creatinine Clearance
- 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.
Rutin + Ascorbic Acid (RUTA C60®)Drug
Also called (RUTA C60®)
Rutin 60 mg combined with ascorbic acid 160 mg, administered orally as two tablets three times daily. Each dose will be given half an hour before the scheduled vancomycin infusion, continued throughout the 14-day study period. The combination is intended to reduce oxidative stress and inflammation associated with vancomycin-induced nephrotoxicity through the antioxidant properties of both agents.
Ascorbic Acid (C-Retard®)Drug
Ascorbic acid 500 mg, administered orally as one sustained-release capsule twice daily. Each dose will be given half an hour before the scheduled vancomycin infusion, continued throughout the 14-day study period. Ascorbic acid is intended to act as an antioxidant, scavenging reactive oxygen species generated by vancomycin therapy to mitigate renal tubular injury.
| Study group | Role | What they receive |
|---|---|---|
| Rutin + Ascorbic Acid (RUTA C60®) | Experimental | Patients in this arm will receive vancomycin plus a fixed-dose combination of rutin 60 mg and ascorbic acid 160 mg (RUTA C60®), given as two tablets three times daily, administered half an hour before each vancomycin dose, for the duration of the 14-day study period. Receives: Drug: Rutin + Ascorbic Acid (RUTA C60®) |
| Ascorbic Acid Alone | Active comparator | Patients in this arm will receive vancomycin plus ascorbic acid 500 mg (C-Retard®), given as one capsule twice daily, administered half an hour before the vancomycin dose, for the duration of the 14-day study period. Receives: Drug: Ascorbic Acid (C-Retard®) |
| Vancomycin Alone | No intervention | Patients in this arm will receive vancomycin therapy alone, with no rutin or ascorbic acid supplementation, following standard dosing protocols for the duration of the 14-day study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Creatinine
Measurement of serum creatinine levels to detect changes indicative of vancomycin-induced nephrotoxicity across the three study groups.
Measured: Daily, from baseline to Day 14
Change in Creatinine Clearance
Creatinine clearance calculated using the Cockcroft-Gault equation (adjusted for body weight/BMI) to assess renal function changes during vancomycin therapy.
Measured: Daily, from baseline to Day 14
Change in Blood Urea Nitrogen (BUN)
Measurement of BUN levels as a marker of renal function and potential nephrotoxic injury.
Measured: Daily, from baseline to Day 14
Change in BUN/Creatinine Ratio
Calculated ratio of BUN to serum creatinine to further characterize the nature and severity of renal impairment.
Measured: Daily, from baseline to Day 14
Change in Plasma NGAL (Neutrophil Gelatinase-Associated Lipocalin)
Plasma NGAL measured as an early biomarker of acute kidney tubular injury, prior to changes in serum creatinine.
Measured: Baseline, Day 3, and Day 14 (end of study)
Secondary outcomes (5)
Change in Serum Potassium
Measurement of serum potassium levels to monitor electrolyte disturbances associated with renal impairment.
Measured: Daily, from baseline to Day 14
Change in Serum Sodium
Measurement of serum sodium levels to monitor electrolyte disturbances associated with renal impairment.
Measured: Daily, from baseline to Day 14
Change in C-Reactive Protein (CRP)
CRP levels measured to assess the systemic inflammatory response during vancomycin therapy and its modulation by antioxidant supplementation.
Measured: Baseline and Day 14 (end of study)
Change in Procalcitonin
Procalcitonin measured as a marker of infection severity and inflammatory response.
Measured: Baseline and Day 14 (end of study)
Change in Total Leukocyte Count
Total leukocyte count measured to assess infection status and inflammatory response over the treatment course.
Measured: Baseline and Day 14 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, interventional, three-arm, parallel-group randomized controlled trial. A total of 120 adult patients requiring vancomycin therapy for MRSA infections will be randomly allocated in a 1:1:1 ratio to one of three parallel groups: (1) vancomycin plus rutin/ascorbic acid combination (RUTA C60®), (2) vancomycin plus ascorbic acid alone (C-Retard®), or (3) vancomycin alone (control). Each group will receive its assigned regimen concurrently with vancomycin for the duration of the 14-day monitoring period, with no crossover between arms. Randomization will be achieved using a computer-generated sequence with block randomization (block size of six) to maintain balanced allocation throughout recruitment.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Essam Aly, Galala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873372
- Sponsor's protocol ID
- FMASU MD233/2026
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, as this was not specified in the informed consent obtained from participants, and no data-sharing infrastructure or repository has been established for this single-center academic study.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rutin and Ascorbic Acid in Reducing The Incidence of Vancomycin Indueced Nephrotoxicity in Adult Patients
- ClinicalTrials.gov ID
- NCT07873372
- Acronym / sponsor ID
- FMASU MD233/2026
- Conditions
- Nephrotoxicity, Acute Kidney Injuries
- Keywords
- Vancomycin, Rutin, Ascorbic Acid, Serum Creatinine, Oxidative Stress, NGAL, Creatinine Clearance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 Oct 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.
Background: Vancomycin, a key antibiotic for MRSA infections, frequently causes nephrotoxicity (kidney damage) via oxidative stress, especially at the higher doses and longer durations now recommended. Antioxidants like rutin and ascorbic acid (vitamin C) have shown promise in reducing this toxicity in preclinical and limited human studies, but no trial has tested them together.
Aim: Evaluate whether combined rutin + ascorbic acid supplementation reduces the incidence of vancomycin-induced nephrotoxicity (VAN) in adult patients, compared to ascorbic acid alone and a control group.
Design: Prospective, open-label, randomized controlled, three-arm clinical trial; 120 adult patients recruited from Internal Medicine departments at Ain Shams University Hospital.
Population: Adults (≥18) receiving vancomycin for ≥7 days for MRSA infections, without prior kidney injury, proteinuria/hematuria, or other antioxidant/nephrotoxic drug use.
Outcomes:
Primary: Changes in serum creatinine, NGAL, BUN, creatinine clearance, BUN/creatinine ratio Secondary: Serum potassium/sodium, CRP, total leukocyte count, procalcitonin
Detailed description
Background \& Rationale Vancomycin is a key antibiotic against MRSA but causes nephrotoxicity in 5-25% of patients (up to 35% with concurrent aminoglycosides), largely via oxidative stress and reactive oxygen species that trigger renal cell apoptosis.
Risk rises with newer high-dose regimens (trough 15-20 mg/L), treatment >5 days, obesity, intermittent infusion, and co-administration with other nephrotoxins (e.g., piperacillin/tazobactam, flucloxacillin).
Antioxidants (N-acetylcysteine, vitamin E) have shown benefit; ascorbic acid and rutin individually have antioxidant/anti-inflammatory effects supported by prior human and animal studies, but no trial has tested the rutin + vitamin C combination specifically for preventing vancomycin nephrotoxicity - this is the gap the study addresses.
Aim of the study:
Evaluate whether rutin + ascorbic acid supplementation reduces vancomycin-induced nephrotoxicity (VAN) versus ascorbic acid alone and versus control.
Study Design:
Prospective, open-label, randomized controlled, three-arm trial Setting: Internal Medicine departments, Ain Shams University Hospital Sample size: 120 patients (40/arm), calculated via G*Power (effect size 0.3, α=0.05, power 80%, adjusted for dropout)
Groups:
Group 1 (Intervention) Vancomycin + Rutin 60mg/Vitamin C 160mg (RUTA C60®), 2 tablets TID, 30 min pre-dose
Group 2 (Intervention) Vancomycin + Vitamin C 500mg (C-Retard®), 1 capsule BID, 30 min pre-dose
Group 3 (control) Vancomycin alone Randomization: Computer-generated block randomization (block size 6); allocation concealed via sequentially numbered, opaque, sealed envelopes (SNOSE).
Eligibility Criteria:
Include: Adults ≥18, MRSA infection needing vancomycin ≥7 days, no concurrent antioxidants, no proteinuria/hematuria/prior AKI Exclude: Drug allergies, pregnancy/lactation, baseline S.cr ≥2mg/dL, concurrent nephrotoxins, urinary stones, upcoming contrast media exposure
Outcomes:
Primary: Serum creatinine, plasma NGAL, BUN, creatinine clearance (Cockcroft-Gault), BUN/creatinine ratio Secondary: Serum K⁺/Na⁺, CRP, total leukocyte count, procalcitonin
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective, interventional, three-arm, parallel-group randomized controlled trial. A total of 120 adult patients requiring vancomycin therapy for MRSA infections will be randomly allocated in a 1:1:1 ratio to one of three parallel groups: (1) vancomycin plus rutin/ascorbic acid combination (RUTA C60®), (2) vancomycin plus ascorbic acid alone (C-Retard®), or (3) vancomycin alone (control). Each group will receive its assigned regimen concurrently with vancomycin for the duration of the 14-day monitoring period, with no crossover between arms. Randomization will be achieved using a computer-generated sequence with block randomization (block size of six) to maintain balanced allocation throughout recruitment.
| Arm | Type | Receives |
|---|---|---|
| Rutin + Ascorbic Acid (RUTA C60®) | Experimental | Drug: Rutin + Ascorbic Acid (RUTA C60®)Patients in this arm will receive vancomycin plus a fixed-dose combination of rutin 60 mg and ascorbic acid 160 mg (RUTA C60®), given as two tablets three times daily, administered half an hour before each vancomycin dose, for the duration of the 14-day study period. |
| Ascorbic Acid Alone | Active comparator | Drug: Ascorbic Acid (C-Retard®)Patients in this arm will receive vancomycin plus ascorbic acid 500 mg (C-Retard®), given as one capsule twice daily, administered half an hour before the vancomycin dose, for the duration of the 14-day study period. |
| Vancomycin Alone | No intervention | –Patients in this arm will receive vancomycin therapy alone, with no rutin or ascorbic acid supplementation, following standard dosing protocols for the duration of the 14-day study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients admitted to different departments of the hospital
- Both genders, aged ≥18 years
- Susceptibility to gram-positive infection (MRSA) requiring vancomycin treatment for at least 7 days
- Not receiving any concurrent antioxidant treatment (e.g., vitamin E)
- Free of proteinuria and/or hematuria
Key exclusion criteria (6 listed)
- Known allergy to vancomycin, ascorbic acid, or rutin
- Pregnant or lactating females
- Baseline serum creatinine ≥2 mg/dL
- Receiving other nephrotoxic drugs at time of initiating vancomycin (e.g., aminoglycosides, colistin, amphotericin B, tacrolimus, cisplatin, or calcineurin inhibitors)
- Urinary tract stones
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 |
|---|---|---|
| Rutin + Ascorbic Acid (RUTA C60®)Also: (RUTA C60®)Rutin 60 mg combined with ascorbic acid 160 mg, administered orally as two tablets three times daily. Each dose will be given half an hour before the scheduled vancomycin infusion, continued throughout the 14-day study period. The combination is intended to reduce oxidative stress and inflammation associated with vancomycin-induced nephrotoxicity through the antioxidant properties of both agents. | Drug | Rutin + Ascorbic Acid (RUTA C60®) |
| Ascorbic Acid (C-Retard®)Ascorbic acid 500 mg, administered orally as one sustained-release capsule twice daily. Each dose will be given half an hour before the scheduled vancomycin infusion, continued throughout the 14-day study period. Ascorbic acid is intended to act as an antioxidant, scavenging reactive oxygen species generated by vancomycin therapy to mitigate renal tubular injury. | Drug | Ascorbic Acid Alone |
Primary outcome
Change in Serum Creatinine
Time frame: Daily, from baseline to Day 14
Measurement of serum creatinine levels to detect changes indicative of vancomycin-induced nephrotoxicity across the three study groups.
Change in Creatinine Clearance
Time frame: Daily, from baseline to Day 14
Creatinine clearance calculated using the Cockcroft-Gault equation (adjusted for body weight/BMI) to assess renal function changes during vancomycin therapy.
Change in Blood Urea Nitrogen (BUN)
Time frame: Daily, from baseline to Day 14
Measurement of BUN levels as a marker of renal function and potential nephrotoxic injury.
Change in BUN/Creatinine Ratio
Time frame: Daily, from baseline to Day 14
Calculated ratio of BUN to serum creatinine to further characterize the nature and severity of renal impairment.
Change in Plasma NGAL (Neutrophil Gelatinase-Associated Lipocalin)
Time frame: Baseline, Day 3, and Day 14 (end of study)
Plasma NGAL measured as an early biomarker of acute kidney tubular injury, prior to changes in serum creatinine.
5 secondary outcomes
Change in Serum Potassium
Time frame: Daily, from baseline to Day 14
Change in Serum Sodium
Time frame: Daily, from baseline to Day 14
Change in C-Reactive Protein (CRP)
Time frame: Baseline and Day 14 (end of study)
Change in Procalcitonin
Time frame: Baseline and Day 14 (end of study)
Change in Total Leukocyte Count
Time frame: Baseline and Day 14 (end of study)
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 14 Oct 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, as this was not specified in the informed consent obtained from participants, and no data-sharing infrastructure or repository has been established for this single-center academic study.
Related trials for Nephrotoxicity
Recruiting
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
Renal Cancer, Renal Secondary Cancer
Not yet recruitingObservational study
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
Biomarkers, Acute Kidney Injury
Active, not recruitingPhase 3
Cisplatin Disposition and Kidney Injury
Nephrotoxicity
Not yet recruitingPhase 1
Safety Study of GMDTC Injection in Participants With Solid Tumors and Cisplatin-Induced Renal Dysfunction
Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
Not yet recruitingObservational study
Differentiating True Nephrotoxicity From Pseudo-nephrotoxicity: A Prospective Comparative Study of Vancomycin Plus Piperacillin-Tazobactam vs. Meropenem Using Serum Creatinine and Cystatin-C
Nephrotoxicity, Bacterial Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rutin + Ascorbic Acid (RUTA C60®) and Ascorbic Acid (C-Retard®) in people with Nephrotoxicity and Acute Kidney Injuries, run by Ain Shams 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 6 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 14 Oct 2026. 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.
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?
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?
Change in Serum Creatinine (time frame: Daily, from baseline to Day 14). The study lists 5 primary outcomes in all. 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 14 Oct 2026.