Clinical trial NCT01936376: A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
Official title: A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Keywords: kidney safety
biomarkers
serum creatinine
BUN
cystic fibrosis
head and neck cancer
renal injury
drug induced acute kidney injury
aminoglycoside
cisplatin
nephrotoxicity
biomarker qualification
Lead sponsor: Foundation for the National Institutes of Health
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: University of Minnesota
name: M.D. Anderson Cancer Center
name: Brigham and Women's Hospital
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Amgen
name: AstraZeneca
name: Eli Lilly and Company
name: Johnson & Johnson
name: Merck Sharp & Dohme LLC
name: Pfizer
name: Critical Path Institute - Predictive Safety Testing Consortium
First posted: 2013-09-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cancer patients

Brief summary: The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

Detailed description: The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.

Eligibility criteria: Inclusion Criteria (Cisplatin Treatment Group):

1. Males and females ≥ 18 years of age
2. Diagnosis of head \& neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:

   * as single agent chemotherapy in conjunction with local radiotherapy course, or
   * as part of the TPF combination (docetaxel, cisplatin, and fluorouracil)
3. Willingness and ability to comply with study procedures and study restrictions
4. Ability to provide written informed consent

Inclusion Criteria (Control Group):

1. Males and females ≥ 18 years of age
2. Diagnosis of head \& neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone)
3. Willingness and ability to comply with study procedures and study restrictions
4. Ability to provide written informed consent

Exclusion Criteria (All Subjects):

1. Chronic kidney disease defined by eGFR \<60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (\>30 mcg/mg creatinine) will be excluded
2. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
3. Any major surgery (i.e. high risk of acute kidney injury) in the previous month
4. Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine
5. Use of creatine supplements within 7 days prior to hospitalization
6. Solid organ transplant recipients
7. Abnormal liver function (serum ALT, AST or total bilirubin \>2xULN)
8. Significant anemia (Hemoglobin \< 10 g/dL)
9. Pregnancy
10. Institutionalized individuals

Primary outcomes:
measure: biomarker change from baseline
timeFrame: up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School - Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Houston
country: United States
facility: University of Texas MD Anderson
state: Texas
Study officials:
affiliation: University of Texas MD Anderson
name: Abdulla Salahudeen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Sushrut Waikar, MD
role: PRINCIPAL_INVESTIGATOR
References: