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NCT01606787 · ClinicalTrials.gov registry record · Phase 3
Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes
A Phase 3 study of Renal Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT01606787 is a Phase 3 study of Renal Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 210 participants, below the 603-participant average among 29 other Renal Cancer trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01606787, a Phase 3 study of Renal Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if a medication called mannitol, can help the kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in urine production (it is a diuretic). For many years, mannitol has been given to patients in the hope it would improve the kidney's circulation, and in doing so reduce the impact of the surgery on the kidney. Mannitol is given during the surgery before the blood supply to the kidney is stopped. The blood supply to the kidney is stopped in order to minimize any blood loss during the removal of the tumor, and also to assist the surgeons view of the kidney anatomy. Once the tumor is removed the blood supply to the kidney is resumed. Sometimes a side effect of this temporary reduction in blood supply to the kidney is the loss of some kidney function. This may happen either in the short term (right away) or long term (months or years later). In studies done on animals, mannitol was able to lessen this damage to kidney function. However, no human study has ever confirmed that mannitol has the same helpful effect in humans. There is some suggestion that it may have no effect. Because sufficient research has yet to be done on humans, many surgeons do not give mannitol. A recent study, conducted at Memorial Sloan Kettering which looked back at patients who had undergone partial nephrectomies, an operation where only the portion of the kidney that contains the tumor is removed and enables the normal, unaffected portion of the kidney to be preserved. The results of this study demonstrated no significant difference in kidney function when the investigators compared patients who were given mannitol to those who were not. The investigators hope that this study will help clarify the effectiveness or not of mannitol on kidney function. During the surgery to remove the kidney tumor, patients will receive either mannitol or a placebo. A placebo, is a harmless medication that has no effects. The impact of ma
Conditions Studied
Interventions
- OTHER placebo
- DRUG mannitol
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2012-05-22 |
| Est. Completion | 2018-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01606787
The ClinicalTrials.gov registry entry for NCT01606787 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 603-participant average among 29 other Renal Cancer trials with a reported enrollment target (65% lower). The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Renal Cancer appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01606787 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01606787 about?
NCT01606787 is a clinical study titled "Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes". The purpose of this study is to determine if a medication called mannitol, can help the kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in urine production (it is a diuretic). For many years, mannitol has been given to patients in the hope it would improve th...
What is the current status of trial NCT01606787?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 210 participants. The study started on 2012-05-22. Estimated completion is 2018-02.
What conditions does trial NCT01606787 study?
This clinical trial studies the following conditions: Renal Cancer.
What interventions are being tested in trial NCT01606787?
The interventions under investigation include: placebo (OTHER), mannitol (DRUG).
Who is sponsoring clinical trial NCT01606787?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01606787 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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