Acute Kidney InjuryPhase 4PRAGMATICNCT02481518
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
A Phase 4 study testing Magnesium in people with Acute Kidney Injury, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Magnesium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2015to Mar 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Eastern Cooperative Oncology Group score 0-2
- First Diagnosed Head and neck cancer and plan for treatment with cisplatin
- Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)
Who cannot join
- Prior treatment with cisplatin before randomization
- Uncontrolled concurrent disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine, Ramathibodi Hospital, Mahidol University
Bangkok, 10400
About this study
The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).
Read the detailed description
Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.
- Conditions
- Acute Kidney Injury
- Being tested
- Magnesium, Control
- Keywords
- Cisplatin nephrotoxicity, Acute kidney injury
- 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.
MagnesiumDrug
Pre loading fluid with Magnesium sulphate 16 milliequivalent plus potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
ControlOther
Also called Normal saline
Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Experimental | Magnesium preloading group : Magnesium preloading for Cisplatin treatment Receives: Drug: Magnesium |
| Control | Active comparator | Control group : Normal saline preloading for cisplatin treatment Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment
Measured: 7 days after cisplatin administration
Secondary outcomes (1)
Nephrotoxicity
Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arkom Nongnuch, MD, Principal investigator, Ramathibodi hospital, Mahidol university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481518
- Sponsor's protocol ID
- 2558/172
- Acronym
- PRAGMATIC
- Status last verified
- Aug 2019
- First submitted
- 17 May 2015
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
- ClinicalTrials.gov ID
- NCT02481518
- Acronym / sponsor ID
- PRAGMATIC / 2558/172
- Conditions
- Acute Kidney Injury
- Keywords
- Cisplatin nephrotoxicity, Acute kidney injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 25 Jun 2015 (estimated)
- 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 purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).
Detailed description
Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Drug: MagnesiumMagnesium preloading group : Magnesium preloading for Cisplatin treatment |
| Control | Active comparator | Other: ControlControl group : Normal saline preloading for cisplatin treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Eastern Cooperative Oncology Group score 0-2
- First Diagnosed Head and neck cancer and plan for treatment with cisplatin
- Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)
Key exclusion criteria (3 listed)
- Prior treatment with cisplatin before randomization
- Uncontrolled concurrent disease
- 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 |
|---|---|---|
| MagnesiumPre loading fluid with Magnesium sulphate 16 milliequivalent plus potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration | Drug | Magnesium |
| ControlAlso: Normal salinePotassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration | Other | Control |
Primary outcome
Acute kidney injury
Time frame: 7 days after cisplatin administration
Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment
1 secondary outcome
Nephrotoxicity
Time frame: up to 12 weeks
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 20 Aug 2019.
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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.
Arkom Nongnuch, MD principal investigator
Ramathibodi hospital, Mahidol 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 Magnesium in people with Acute Kidney Injury, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 3 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 20 Aug 2019. 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 Thailand. 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?
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?
Acute kidney injury (time frame: 7 days after cisplatin administration). 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 20 Aug 2019.