Recruiting

Acute Kidney Injury

Sponsor:

NIH

Code:

NCT01936376

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Head and Neck Cancer

Study ID

NCT01936376

Start date

Sep, 2012

Status verified date

Jul, 2014

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

head & neck cancer patients, cisplatin treatment

cancer patients, no cisplatin, no nephrotoxic agent

Primary outcome measure

  • biomarker change from baseline [ Time Frame: up to 3 weeks ]

Central Contacts and Locations

Central contacts

Stefan Sultana, MD

stefan.sultana@novartis.com

Jessica Ratay, MS

(301) 435-4038jratay@fnih.org

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator:

Robert Haddad, MD

University of Texas MD Anderson

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Bonnie Glisson, MD

More Information

Sponsor

Foundation for the National Institutes of Health

Last update posted

Jan 27, 2015

Last verified

Jul, 2014

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Foundation for the National Institutes of Health on 2015-01-27.