Cis-Platinum NephropathyPhase 2/3MACINNCT04251689
The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
A Phase 2/3 study testing Mannitol in people with Cis-Platinum Nephropathy and Mannitol Adverse Reaction, run by Phramongkutklao College of Medicine and Hospital at 1 site in Thailand.
Trial summary
This study include cancer patients who had received chemotherapy that include cisplatin. Patients were randomly assigned to either a mannitol 20 g intravenous single dose after cisplatin or a placebo (saline). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cis-Platinum Nephropathy, Mannitol Adverse Reaction
- What is being tested?
- Mannitol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2018to 14 Feb 2021
- Phase
- Phase 2/3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who was at least 18 years old.
- Patients who had been diagnosed with cancer proven by tissue biopsy.
- Patients who were scheduled to receive cisplatin or combination of cisplatin and other chemotherapy, which the dose of cisplatin was not exceeded 100 mg/m2.
- Patients were required to have a normal renal function (GFR > 60 mL/min/1.73m2).
- Patients with an Eastern Cooperative Oncology Group (ECOG) score ≤ 2.
- Patients with normal serum sodium and serum potassium level.
Who cannot join
- Patients with any acute kidney injury event before randomized into trial not more than 6 months.
- Patients with chronic kidney disease or hydronephrosis.
- Patients with history of nephrectomy.
- Patients who had previously received immunosuppressants for any immune deficiency disease.
- Patients with who had received chemotherapy which induce nephrotoxicity.
- Patients with had received drug which is nephrotoxic (amphotericin B, aminoglycoside or non-steroidal anti-inflammatory drug).
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- Patients who had cirrhosis with child pugh score more than 7.
- Patients with or had a known allergy to cisplatin or mannitol.
- Patients with chronic heart failure who cannot received fluid more than 1 liter.
- Patients who were not comfortable to follow up at clinic for long term outcome.
Trial locations and contacts
1 site in 1 country.
About this study
This study include cancer patients who had received chemotherapy that include cisplatin. Patients were randomly assigned to either a mannitol 20 g intravenous single dose after cisplatin or a placebo (saline). The primary outcome was to compare acute kidney injury (AKI), which was defined as increase creatinine 0.3 mg/dl in 48 hours by KDIGO criteria using serum creatinine and 24 hour urine creatinine to calculated.
- Being tested
- Mannitol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
PlaceboDrug
0.9% normal saline 100 ml
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin Receives: Drug: Mannitol |
| placebo | Placebo comparator | 0.9% normal saline 100 ml one hour after cisplatin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
Rate of patients with serum creatinine increase 0.3 mg/dl or ≥50% or urine output of <0.5 mL/kg/hour for >6 hours by AKIN criteria
Measured: 48 hours
Secondary outcomes (1)
Decline 24-hour urine creatinine clearance
Rate of patients with lower than 60 mL/min/1.73m2 of 24-hour urine creatinine clearance after receiving cisplatin
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Dec 2018
- Primary completion1 Jul 2020
- Study completion14 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cis-Platinum NephropathyStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phramongkutklao College of Medicine and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251689
- Sponsor's protocol ID
- R023h/62
- Acronym
- MACIN
- Status last verified
- Jan 2022
- First submitted
- 30 Jan 2020
- Last updated
- 21 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Mannitol Plus Saline on the Prevention of Cisplatin-induced Nephrotoxicity: A Randomized, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04251689
- Acronym / sponsor ID
- MACIN / R023h/62
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Phramongkutklao College of Medicine and HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 14 Feb 2021 (actual)
- First posted
- 5 Feb 2020 (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 study include cancer patients who had received chemotherapy that include cisplatin. Patients were randomly assigned to either a mannitol 20 g intravenous single dose after cisplatin or a placebo (saline). The primary outcome was to compare acute kidney injury (AKI), which was defined as increase creatinine 0.3 mg/dl in 48 hours by KDIGO criteria using serum creatinine and 24 hour urine creatinine to calculated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: Mannitolmannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin |
| placebo | Placebo comparator | Drug: Placebo0.9% normal saline 100 ml one hour after cisplatin |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who was at least 18 years old.
- Patients who had been diagnosed with cancer proven by tissue biopsy.
- Patients who were scheduled to receive cisplatin or combination of cisplatin and other chemotherapy, which the dose of cisplatin was not exceeded 100 mg/m2.
- Patients were required to have a normal renal function (GFR > 60 mL/min/1.73m2).
- Patients with an Eastern Cooperative Oncology Group (ECOG) score ≤ 2.
Key exclusion criteria (10 listed)
- Patients with any acute kidney injury event before randomized into trial not more than 6 months.
- Patients with chronic kidney disease or hydronephrosis.
- Patients with history of nephrectomy.
- Patients who had previously received immunosuppressants for any immune deficiency disease.
- Patients with who had received chemotherapy which induce nephrotoxicity.
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 |
|---|---|---|
| MannitolMannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin | Drug | intervention |
| Placebo0.9% normal saline 100 ml | Drug | placebo |
Primary outcome
Acute Kidney Injury
Time frame: 48 hours
Rate of patients with serum creatinine increase 0.3 mg/dl or ≥50% or urine output of <0.5 mL/kg/hour for >6 hours by AKIN criteria
1 secondary outcome
Decline 24-hour urine creatinine clearance
Time frame: 48 hours
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 21 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Cis-Platinum Nephropathy
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Hydronephrosis, Infiltrating Bladder Urothelial Carcinoma Sarcomatoid Variant
RecruitingPhase 2
A Double-blind Non Inferiority Clinical Trial to Compare the Nephroprotection of Cilastatn Versus Thiosulfate in Patients Undergoing Debulking Surgery With Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Cisplatin.
Debulking Surgery for Ovarian Cancer, Acute Kidney Injury
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Prevention of Cisplatin-induced Nephrotoxicity
Acute Kidney Injury, Renal Tubulopathy
Not yet recruitingPhase 2/3
N-Acetylcysteine Roles in Preserving Renal Function Measured by Urinary KIM-1 (Kidney Injury Molecule-1) and Serum Creatinine on Cancer Patients With Cisplatin Based Chemotherapy: A Randomized Placebo-Controlled Trial
Kidney Function Issue, Acute Kidney Injury
RecruitingObservational study
Cisplatin Induced Kidney Toxicity
Acute Kidney Injury, Cancer
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 Phase 2/3 study testing Mannitol in people with Cis-Platinum Nephropathy and Mannitol Adverse Reaction, run by Phramongkutklao College of Medicine and Hospital 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 6 inclusion and 10 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 21 Jan 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: 48 hours). 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 21 Jan 2022.