Cystic Fibrosis Clinical Trial
Official title:
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
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.
The goal of this clinical study is to advance the acceptance of new biomarkers designed to
detect drug-induced kidney injury in clinical trials.
The Kidney Safety Project is being conducted at four major medical centers:
- University of Southern California
- University of Minnesota
- MD Anderson Cancer Center
- Dana-Farber Cancer Institute.
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. Aminoglycosides are a common antibiotic drug taken by
patients with cystic fibrosis. Cisplatin is a common chemotherapy drug taken by patients
with head and neck cancer.
The Aminoglycoside Study of the Kidney Safety Project is being conducted at the University
of Southern California and the University of Minnesota and aims to evaluate aminoglycoside
induced acute kidney injury in patients with cystic fibrosis.
The companion study, the Cisplatin Study of the Kidney Safety Project, is being conducted at
the MD Anderson Cancer Center and the Dana-Farber Cancer Institute and aims to evaluate
cisplatin induced acute kidney injury in patients with head and neck cancer.
The data from the Kidney Safety Project, from both the Aminoglycoside Study and the
Cisplatin Study, will be combined for determination of the best biomarkers for predicting
drug-induced acute kidney injury.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04696198 -
Thoracic Mobility in Cystic Fibrosis Care
|
N/A | |
| Completed |
NCT00803205 -
Study of Ataluren (PTC124™) in Cystic Fibrosis
|
Phase 3 | |
| Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
| Completed |
NCT03601637 -
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
|
Phase 3 | |
| Terminated |
NCT02769637 -
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
|
||
| Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
| Recruiting |
NCT06032273 -
Lung Transplant READY CF 2: CARING CF Ancillary RCT
|
N/A | |
| Recruiting |
NCT06030206 -
Lung Transplant READY CF 2: A Multi-site RCT
|
N/A | |
| Recruiting |
NCT05392855 -
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
|
N/A | |
| Recruiting |
NCT06088485 -
The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
|
||
| Recruiting |
NCT04056702 -
Impact of Triple Combination CFTR Therapy on Sinus Disease.
|
||
| Recruiting |
NCT04039087 -
Sildenafil Exercise: Role of PDE5 Inhibition
|
Phase 2/Phase 3 | |
| Completed |
NCT04058548 -
Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation
|
N/A | |
| Completed |
NCT04038710 -
Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease.
|
||
| Completed |
NCT03637504 -
Feasibility of a Mobile Medication Plan Application in CF Patient Care
|
N/A | |
| Recruiting |
NCT03506061 -
Trikafta in Cystic Fibrosis Patients
|
Phase 2 | |
| Completed |
NCT03566550 -
Gut Imaging for Function & Transit in Cystic Fibrosis Study 1
|
||
| Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
| Completed |
NCT04568980 -
Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
|
||
| Recruiting |
NCT04010253 -
Impact of Bronchial Drainage Technique by the Medical Device Simeox® on Respiratory Function and Symptoms in Adult Patients With Cystic Fibrosis
|
N/A |