NCT06215976

Brief 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 cancer.
  • To evaluate the safety of combining cisplatin and metformin on patients with bladder cancer

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

December 16, 2023

Last Update Submit

August 19, 2024

Conditions

Muscle-Invasive Bladder Carcinoma

Keywords

Metformincisplatinnephroprotective effectnephrotoxicitybladder cancer

Outcome Measures

Primary Outcomes (4)

  • serum creatinine (SCr)

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

    12 week

  • Human Neutrophil gelatinase-associated lipocalin (NGAL)

    to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

    12 week

  • Cystatin C

    to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

    12 week

  • Estimated glomerular filtration rate (eGFR)

    to assess the nephroprotective effect of metformin against cisplatin induced nephrotoxicity

    12 week

Secondary Outcomes (6)

  • FBG

    12 week

  • HbA1C

    12 week

  • Body weight

    12 week

  • Body Mass Index

    12 week

  • Blood pH

    12 week

  • +1 more secondary outcomes

Study Arms (2)

Metformin

ACTIVE COMPARATOR

(39) patients taking metformin (500 mg twice daily) with cisplatin (70 mg/m2) and gemcitabine (1000 mg/m2) (GC) protocol

Drug: Metformin Hydrochloride 500 MG

Control

NO INTERVENTION

(39) patients taking cisplatin (70 mg/m2) gemcitabine (1000 mg/m2) (GC) protocol without metformin

Interventions

Metformin Hydrochloride 500 MGDRUG

Metformin 500mg tablets twice daily

Metformin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of pharmacy Cairo university

Cairo, Egypt

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40319155DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Samar Farid

    faculty of pharmacy Cairo University

    STUDY CHAIR

Central Study Contacts

Samah Essam Saber Mahran

CONTACT

0201094164048samah.essam@pharma.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2023

First Posted

January 22, 2024

Study Start

June 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 30, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG(1)