Cisplatin NephrotoxicityPhase 2NCT02760901
Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
A Phase 2 study testing Acetazolamide, Acetylcysteine and Mannitol in people with Cisplatin Nephrotoxicity, run by Ain Shams University.
Trial summary
Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose cisplatin undergo severe renal dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cisplatin Nephrotoxicity
- What is being tested?
- Acetazolamide, Acetylcysteine and Mannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Oct 2016
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients to receive cisplatin based chemotherapy protocol.
- Adult patients from 18 to 65 years.
Who cannot join
- Existing renal impairment ( Creatinine clearance <30 ml/minute)
- Severe hepatic impairment (Child Pugh score C).
- Hypersensitivity to sulfonamides.
- Patients with chronic non-congestive angle closure glaucoma.
- Hypersensitivity to sulphur compounds, N-acetylcysteine or any component of the formulation.
About this study
Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC) ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.
Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans compared to mannitol and to each other.
Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed using RIFLE criteria. Patients' liver function tests and hematological parameters were also monitored.
- Conditions
- Cisplatin Nephrotoxicity
- Being tested
- Acetazolamide, Acetylcysteine, Mannitol, saline, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called ACTZ
patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
AcetylcysteineDrug
Also called NAC
patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
MannitolDrug
patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
salineDrug
saline hydration 2500 ml before cisplatin therapy
CisplatinDrug
patients with tumours already prescribed cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Mannitol group | Active comparator | patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration. Receives: Drug: Mannitol; Drug: saline; Drug: Cisplatin |
| ACTZ group | Active comparator | patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration. Receives: Drug: Acetazolamide; Drug: saline; Drug: Cisplatin |
| NAC group | Active comparator | patients received acetylcysteine NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration. Receives: Drug: Acetylcysteine; Drug: saline; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Creatinine
Blood samples collected and measured in laboratory with the unit mg/dL
Measured: change from baseline after 3 cycles separated by 21 days
Creatinine clearance according to Cockroft-Gault equation
calculated using globalrph calculators , unit ml/min
Measured: change from baseline after 3 cycles separated by 21 days
Acute kidney injury
Acute kidney injury assessed by RIFLE criteria that was calculated for patients
Measured: change from baseline after 3 cycles separated by 21 days
Blood urea nitrogen (BUN)
Blood samples collected and measured in laboratory with the unit mg/dl
Measured: change from baseline after 3 cycles separated by 21 days
Secondary outcomes (6)
Aspartate Transaminase (AST)
Liver function tests were monitored by measuring AST for change from baseline after 3 cycles separated by 21 days
Measured: change from baseline after 3 cycles separated by 21 days
hemoglo bin
hemoglobin concentration g/dl was monitored for change from baseline after 3 cycles separated by 21 days
Measured: change from baseline after 3 cycles separated by 21 days
adverse events
Monitoring adverse events: to evaluate the difference between three groups regarding frequency of adverse events.
Measured: change from baseline after 3 cycles separated by 21 days
Alanine Transaminase (ALT)
Liver function tests were monitored by measuring ALT for change from baseline after 3 cycles separated by 21 days
Measured: change from baseline after 3 cycles separated by 21 days
platelets count
platelets count cells per ml was monitored for change from baseline after 3 cycles separated by 21 days
Measured: change from baseline after 3 cycles separated by 21 days
total leucocyte count
total leucocyte count cells per ml was monitored for change from baseline after 3 cycles separated by 21 days
Measured: change from baseline after 3 cycles separated by 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startNov 2013
- Primary completionOct 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cisplatin NephrotoxicityStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Kamal Morsy Ibraheem, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760901
- Sponsor's protocol ID
- master
- Status last verified
- Jan 2017
- First submitted
- 1 Apr 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity
- ClinicalTrials.gov ID
- NCT02760901
- Acronym / sponsor ID
- master
- Conditions
- Cisplatin Nephrotoxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 May 2016 (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.
Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC) ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans.
Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans compared to mannitol and to each other.
Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed using RIFLE criteria. Patients' liver function tests and hematological parameters were also monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mannitol group | Active comparator | Drug: Mannitol, Drug: saline, Drug: Cisplatinpatients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration. |
| ACTZ group | Active comparator | Drug: Acetazolamide, Drug: saline, Drug: Cisplatinpatients received acetazolamide 250 mg half an hour before cisplatin with saline hydration. |
| NAC group | Active comparator | Drug: Acetylcysteine, Drug: saline, Drug: Cisplatinpatients received acetylcysteine NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer patients to receive cisplatin based chemotherapy protocol.
- Adult patients from 18 to 65 years.
Key exclusion criteria (5 listed)
- Existing renal impairment ( Creatinine clearance <30 ml/minute)
- Severe hepatic impairment (Child Pugh score C).
- Hypersensitivity to sulfonamides.
- Patients with chronic non-congestive angle closure glaucoma.
- Hypersensitivity to sulphur compounds, N-acetylcysteine or any component of the formulation.
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 |
|---|---|---|
| AcetazolamideAlso: ACTZpatients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity | Drug | ACTZ group |
| AcetylcysteineAlso: NACpatients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity | Drug | NAC group |
| Mannitolpatients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration. | Drug | Mannitol group |
| salinesaline hydration 2500 ml before cisplatin therapy | Drug | ACTZ group, Mannitol group, NAC group |
| Cisplatinpatients with tumours already prescribed cisplatin | Drug | ACTZ group, Mannitol group, NAC group |
Primary outcome
Serum Creatinine
Time frame: change from baseline after 3 cycles separated by 21 days
Blood samples collected and measured in laboratory with the unit mg/dL
Creatinine clearance according to Cockroft-Gault equation
Time frame: change from baseline after 3 cycles separated by 21 days
calculated using globalrph calculators , unit ml/min
Acute kidney injury
Time frame: change from baseline after 3 cycles separated by 21 days
Acute kidney injury assessed by RIFLE criteria that was calculated for patients
Blood urea nitrogen (BUN)
Time frame: change from baseline after 3 cycles separated by 21 days
Blood samples collected and measured in laboratory with the unit mg/dl
6 secondary outcomes
Aspartate Transaminase (AST)
Time frame: change from baseline after 3 cycles separated by 21 days
hemoglo bin
Time frame: change from baseline after 3 cycles separated by 21 days
adverse events
Time frame: change from baseline after 3 cycles separated by 21 days
Alanine Transaminase (ALT)
Time frame: change from baseline after 3 cycles separated by 21 days
platelets count
Time frame: change from baseline after 3 cycles separated by 21 days
total leucocyte count
Time frame: change from baseline after 3 cycles separated by 21 days
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 24 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide, Acetylcysteine and Mannitol in people with Cisplatin Nephrotoxicity, run by Ain Shams University.
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 2 inclusion and 5 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Serum Creatinine (time frame: change from baseline after 3 cycles separated by 21 days). The study lists 4 primary outcomes in all. 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 24 Jan 2017.