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The Nephroprotective Effect of Metformin With Cisplatin in Bladder Cancer

ConditionMuscle-Invasive Bladder Carcinoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Metformin Hydrochloride 500 MG

    Drug

    Metformin 500mg tablets twice daily

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: MetforminActive comparator 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

serum creatinine (SCr)

to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity.

Time frame
12 week
2

Human Neutrophil gelatinase-associated lipocalin (NGAL)

to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

Time frame
12 week
3

Cystatin C

to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

Time frame
12 week
4

Estimated glomerular filtration rate (eGFR)

to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

Time frame
12 week

Secondary outcomes

1

FBG

to assess the safety of using cisplatin-metformin combination in bladder cancer patients receiving cisplatin

Time frame
12 week
2

HbA1C

to assess the safety of using cisplatin-metformin combination in bladder cancer patients

Time frame
12 week
3

Body weight

to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)

Time frame
12 week
4

Body Mass Index

to assess the safety of using cisplatin-metformin combination in bladder cancer patients (monitoring weight loss)

Time frame
12 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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