Muscle-Invasive Bladder CarcinomaPhase 4NCT06215976
The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
A Phase 4 study testing Metformin Hydrochloride 500 MG in people with Muscle-Invasive Bladder Carcinoma, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are: To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- What is being tested?
- Metformin Hydrochloride 500 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 30 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-diabetic adults of age between 18 to 65.
- Chemotherapy naïve patients diagnosed with bladder cancer.
- Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2
Who cannot join
- Patients with history of lactic acidosis.
- Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin).
- Unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dL or greater suddenly in 48 hours according to the acute kidney injury network (AKIN) classification
- Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock).
- Severe infection and sepsis.
- Any infection requiring hospitalization.
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- Any infection leading to a need for oxygen, intubation, vasopressors or fluids to support blood pressure.
- Alcohol intake.
- Respiratory failure.
- Severe hepatic impairment (Child-Pugh class C).
- Patients with metastasis.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of pharmacy Cairo university
Cairo
Samah Essam Saber Mahran, 0201094164048, samah.essam@pharma.cu.edu.eg
About this study
The goal of this clinical trial is to evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are:
- To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer.
- To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Being tested
- Metformin Hydrochloride 500 MG
- Keywords
- Metformin, cisplatin, nephroprotective effect, nephrotoxicity, bladder cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin Hydrochloride 500 MGDrug
Metformin 500mg tablets twice daily
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | (39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol Receives: Drug: Metformin Hydrochloride 500 MG |
| Control | No intervention | (39) patients taking cisplatin (70 mg/m2) gemcitabine (1000 mg/m2) (GC) protocol without metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine (SCr)
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.
Measured: 12 week
Human Neutrophil gelatinase-associated lipocalin (NGAL)
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Measured: 12 week
Cystatin C
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Measured: 12 week
Estimated glomerular filtration rate (eGFR)
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Measured: 12 week
Secondary outcomes (6)
FBG
to assess the safety of using cisplatin-metformin combination in bladder cancer patients receiving cisplatin
Measured: 12 week
HbA1C
to assess the safety of using cisplatin-metformin combination in bladder cancer patients
Measured: 12 week
Body weight
to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)
Measured: 12 week
Body Mass Index
to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)
Measured: 12 week
Blood pH
to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any)
Measured: 12 week
Blood Lactate Level
to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring lactic acidosis if any)
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Essam Saber Mahran, Cairo University
- Investigators
- Samar Farid, Study chair, faculty of pharmacy Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215976
- Sponsor's protocol ID
- CL (3164)
- Status last verified
- Aug 2024
- First submitted
- 16 Dec 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mahran SE, Salem SE, Sabry NA, Farid SF. The nephroprotective effect of metformin with cisplatin in bladder cancer: randomized clinical trial. Int Urol Nephrol. 2025 Nov;57(11):3611-3624. doi: 10.1007/s11255-025-04505-2. Epub 2025 May 3.
PubMed 40319155
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer
- ClinicalTrials.gov ID
- NCT06215976
- Acronym / sponsor ID
- CL (3164)
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Keywords
- Metformin, cisplatin, nephroprotective effect, nephrotoxicity, bladder cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Jan 2024 (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 evaluate the protective effect of metformin on nephrotoxicity of cisplatin in patients with bladder cancer. The main questions it aims to answer are:
- To determine protective effect of metformin on structural and functional kidney injury caused by cisplatin in patients with bladder cancer.
- To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin Hydrochloride 500 MG(39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol |
| Control | No intervention | –(39) patients taking cisplatin (70 mg/m2) gemcitabine (1000 mg/m2) (GC) protocol without metformin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-diabetic adults of age between 18 to 65.
- Chemotherapy naïve patients diagnosed with bladder cancer.
- Patients with stable renal function: eGFR is above 60 ml/min/1.73 m2
Key exclusion criteria (11 listed)
- Patients with history of lactic acidosis.
- Patients taking any nephrotoxic medication other than cisplatin (e.g., frusemide, NSAIDs, aminoglycoside or vancomycin).
- Unstable renal function (defined as an increase in serum creatinine of 0.3 mg/dL or greater suddenly in 48 hours according to the acute kidney injury network (AKIN) classification
- Patients with heart failure, acute myocardial infarction or cardiogenic collapse (shock).
- Severe infection and sepsis.
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 |
|---|---|---|
| Metformin Hydrochloride 500 MGMetformin 500mg tablets twice daily | Drug | Metformin |
Primary outcome
serum creatinine (SCr)
Time frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.
Human Neutrophil gelatinase-associated lipocalin (NGAL)
Time frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Cystatin C
Time frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
Estimated glomerular filtration rate (eGFR)
Time frame: 12 week
to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity
6 secondary outcomes
FBG
Time frame: 12 week
HbA1C
Time frame: 12 week
Body weight
Time frame: 12 week
Body Mass Index
Time frame: 12 week
Blood pH
Time frame: 12 week
Blood Lactate Level
Time frame: 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 40319155Mahran SE, Salem SE, Sabry NA, Farid SF. The nephroprotective effect of metformin with cisplatin in bladder cancer: randomized clinical trial. Int Urol Nephrol. 2025 Nov;57(11):3611-3624. doi: 10.1007/s11255-025-04505-2. Epub 2025 May 3.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Samar Farid study chair
faculty of pharmacy Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin Hydrochloride 500 MG in people with Muscle-Invasive Bladder Carcinoma, run by Cairo 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 20 Aug 2024. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samah Essam Saber Mahran (0201094164048, samah.essam@pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine (SCr) (time frame: 12 week). The study lists 4 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 NCT06215976, which also lists 1 linked publication.
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 20 Aug 2024.