Cisplatin-induced NephrotoxicityNCT07874373
Magnesium Supplementation for the Prevention of Cisplatin-Induced Nephrotoxicity
A study testing Magnesium sulphate, Furosemide and Saline (0.9% NaCl) in people with Cisplatin-induced Nephrotoxicity, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
This prospective, randomized, open-label study evaluated whether intravenous magnesium sulphate added to standard hydration could reduce cisplatin-associated renal toxicity in adult patients with solid tumors receiving weekly cisplatin-based chemoradiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cisplatin-induced Nephrotoxicity
- What is being tested?
- Magnesium sulphate, Furosemide and Saline (0.9% NaCl)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteRomania
- Study dates
- 1 Mar 2021to 31 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Histologically confirmed cancer diagnosis by biopsy or surgery
- Any cancer type and disease stage eligible for cisplatin-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Baseline creatinine clearance >60 mL/min or serum creatinine <1.5 mg/dL
Who cannot join
- Previous cisplatin chemotherapy
- Creatinine clearance <60 mL/min
- ECOG performance status ≥3
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Cisplatin Nephrotoxicity in Cancer Patients
This prospective, randomized, open-label study evaluated whether intravenous magnesium sulphate added to standard hydration could reduce cisplatin-associated renal toxicity in adult patients with solid tumors receiving weekly cisplatin-based chemoradiotherapy. Participants were assigned to standard hydration with intravenous saline and furosemide or to the same hydration protocol supplemented with 1 g of intravenous magnesium sulphate before cisplatin administration. The primary outcome was early renal toxicity assessed 48 hours after cisplatin administration. Secondary outcomes included renal dysfunction at one year, changes in urinary kidney injury biomarkers (KIM-1, NGAL, and suPAR), hematological toxicity, and treatment response
- Conditions
- Cisplatin-induced Nephrotoxicity
- Being tested
- Magnesium sulphate, Furosemide, Saline (0.9% NaCl)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
1 g intravenously before cisplatin administration, administered with the pre-hydration regimen.
FurosemideDrug
20 mg intravenously before cisplatin administration as part of the hydration protocol.
Saline (0.9% NaCl)Drug
1 L of 0.9% sodium chloride before cisplatin and 1 L after cisplatin.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Standard hydration protocol | Active comparator | Participants received 1 L of 0.9% sodium chloride solution with 20 mg of intravenous furosemide over 1 hour before cisplatin administration, followed by 1 L of 0.9% sodium chloride solution over 2 hours after cisplatin Receives: Drug: Furosemide; Drug: Saline (0.9% NaCl) |
| Arm 2- Magnesium Supplemented Hydration protocol | Experimental | Participants received 1 L of 0.9% sodium chloride solution with 1 g of intravenous magnesium sulphate and 20 mg of intravenous furosemide over 1 hour before cisplatin administration, followed by 1 L of 0.9% sodium chloride solution over 2 hours after cisplatin. Oral magnesium supplementation of 250-500 mg/day was recommended between chemotherapy cycles when serum magnesium was below 1.8 mg/dL before a subsequent cycle. Pasted text
La Interventions, aș crea: Receives: Drug: Magnesium sulphate; Drug: Furosemide; Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Early Cisplatin-Associated Renal Toxicity
Measured: 48 hours after the first cisplatin administration (Day 3)
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 Mar 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cisplatin-induced NephrotoxicityStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hogas Simona, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874373
- Sponsor's protocol ID
- 6986/21.04.2020
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Prevention of Cisplatin Nephrotoxicity in Cancer Patients
- ClinicalTrials.gov ID
- NCT07874373
- Acronym / sponsor ID
- 6986/21.04.2020
- Conditions
- Cisplatin-induced Nephrotoxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- 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.
This prospective, randomized, open-label study evaluated whether intravenous magnesium sulphate added to standard hydration could reduce cisplatin-associated renal toxicity in adult patients with solid tumors receiving weekly cisplatin-based chemoradiotherapy. Participants were assigned to standard hydration with intravenous saline and furosemide or to the same hydration protocol supplemented with 1 g of intravenous magnesium sulphate before cisplatin administration. The primary outcome was early renal toxicity assessed 48 hours after cisplatin administration. Secondary outcomes included renal dysfunction at one year, changes in urinary kidney injury biomarkers (KIM-1, NGAL, and suPAR), hematological toxicity, and treatment response
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Standard hydration protocol | Active comparator | Drug: Furosemide, Drug: Saline (0.9% NaCl)Participants received 1 L of 0.9% sodium chloride solution with 20 mg of intravenous furosemide over 1 hour before cisplatin administration, followed by 1 L of 0.9% sodium chloride solution over 2 hours after cisplatin |
| Arm 2- Magnesium Supplemented Hydration protocol | Experimental | Drug: Magnesium sulphate, Drug: Furosemide, Drug: Saline (0.9% NaCl)Participants received 1 L of 0.9% sodium chloride solution with 1 g of intravenous magnesium sulphate and 20 mg of intravenous furosemide over 1 hour before cisplatin administration, followed by 1 L of 0.9% sodium chloride solution over 2 hours after cisplatin. Oral magnesium supplementation of 250-500 mg/day was recommended between chemotherapy cycles when serum magnesium was below 1.8 mg/dL before a subsequent cycle. Pasted text La Interventions, aș crea: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Histologically confirmed cancer diagnosis by biopsy or surgery
- Any cancer type and disease stage eligible for cisplatin-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Baseline creatinine clearance >60 mL/min or serum creatinine <1.5 mg/dL
Key exclusion criteria (4 listed)
- Previous cisplatin chemotherapy
- Creatinine clearance <60 mL/min
- ECOG performance status ≥3
- Pregnancy
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 |
|---|---|---|
| Magnesium sulphate1 g intravenously before cisplatin administration, administered with the pre-hydration regimen. | Drug | Arm 2- Magnesium Supplemented Hydration protocol |
| Furosemide20 mg intravenously before cisplatin administration as part of the hydration protocol. | Drug | Arm 1- Standard hydration protocol, Arm 2- Magnesium Supplemented Hydration protocol |
| Saline (0.9% NaCl)1 L of 0.9% sodium chloride before cisplatin and 1 L after cisplatin. | Drug | Arm 1- Standard hydration protocol, Arm 2- Magnesium Supplemented Hydration protocol |
Primary outcome
Incidence of Early Cisplatin-Associated Renal Toxicity
Time frame: 48 hours after the first cisplatin administration (Day 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Cisplatin-induced Nephrotoxicity
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Alpha-Lipoic Acid in Mitigating Cisplatin-Induced Nephrotoxicity
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Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity
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Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity
Solid Tumors, Cisplatin Nephrotoxicity
Not yet recruitingPhase 2/3
Prevention of Cisplatin-induced Nephrotoxicity
Acute Kidney Injury, Renal Tubulopathy
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.
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 Magnesium sulphate, Furosemide and Saline (0.9% NaCl) in people with Cisplatin-induced Nephrotoxicity, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
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 5 inclusion and 4 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 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 Romania. 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?
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?
Incidence of Early Cisplatin-Associated Renal Toxicity (time frame: 48 hours after the first cisplatin administration (Day 3)). 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.