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Phase 3 Trial of Intravenous Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Renal Cancer

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Trial Information

Phase 3 Trial of Intravenous Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes


Inclusion Criteria:



- Age > or = to 18 years

- Scheduled for partial nephrectomy at MSKCC (open or minimally invasive technique)
during which renal ischemia is anticipated

- Preoperative eGFR > 45 cc/min/1.73m2 as measured by the CKD-EPI study equation

Exclusion Criteria:

- Allergy to mannitol

- Severe renal impairment (stage 3B) defined as eGFR < 45 cc/min/1.73m2 as measured by
the CKD-EPI calculation.

- Combined major surgical cases that include a partial nephrectomy.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

difference in eGFR

Outcome Description:

The difference will be assessed with an ANCOVA model with eGFR 6 months after surgery (+/- 1 month) as the outcome and treatment group, surgical technique, and preoperative eGFR as covariates. We will report a two-tailed p-value and a 95% confidence interval for the difference between groups. If a patient does not have an eGFR measurement between 5-7 months after surgery and has both a measurement between 3-5 months and 7-12 months after surgery, then the 6 month eGFR measurement will be linearly interpolated.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Jonathan Coleman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-079

NCT ID:

NCT01606787

Start Date:

May 2012

Completion Date:

May 2014

Related Keywords:

  • Renal Cancer
  • Kidney
  • MANNITOL
  • PLACEBO
  • Partial Nephrectomy
  • 12-079
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Ischemia

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021