NCT01936376

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 27, 2015

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

August 29, 2013

Last Update Submit

January 23, 2015

Conditions

Head and Neck Cancer

Keywords

kidney safetybiomarkersserum creatinineBUNcystic fibrosishead and neck cancerrenal injurydrug induced acute kidney injuryaminoglycosidecisplatinnephrotoxicitybiomarker qualification

Outcome Measures

Primary Outcomes (1)

  • biomarker change from baseline

    up to 3 weeks

Study Arms (2)

head & neck cancer patients, cisplatin treatment

cancer patients, no cisplatin, no nephrotoxic agent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

cancer patients

You may qualify if:

  • Males and females ≥ 18 years of age
  • 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)
  • Willingness and ability to comply with study procedures and study restrictions
  • Ability to provide written informed consent
  • Males and females ≥ 18 years of age
  • 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)
  • Willingness and ability to comply with study procedures and study restrictions
  • Ability to provide written informed consent

You may not qualify if:

  • 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
  • Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
  • Any major surgery (i.e. high risk of acute kidney injury) in the previous month
  • Patients currently receiving trimethoprim or cimetidine or other medications known to alter the tubular secretion of creatinine
  • Use of creatine supplements within 7 days prior to hospitalization
  • Solid organ transplant recipients
  • Abnormal liver function (serum ALT, AST or total bilirubin \>2xULN)
  • Significant anemia (Hemoglobin \< 10 g/dL)
  • Pregnancy
  • Institutionalized individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Harvard Medical School - Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Texas MD Anderson

Houston, Texas, 77030, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and blood

MeSH Terms

Conditions

Head and Neck NeoplasmsCystic Fibrosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Abdulla Salahudeen, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

  • Sushrut Waikar, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Sultana, MD

CONTACT

stefan.sultana@novartis.com

Jessica Ratay, MS

CONTACT

(301) 435-4038jratay@fnih.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2013

First Posted

September 6, 2013

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 27, 2015

Record last verified: 2014-07

Locations

US(3)