From Channel 10, Columbus, Ohio, by KARINA NOVA
Fans tailgating near Ohio State’s campus for the Nebraska game may have seen a phone number flying high above.
A man desperate to save his own life is hoping someone will call it.
After being diagnosed with polycystic kidney disease 7 years ago, Thom Kent tells 10TV’s Karina Nova what he's hoping for is the gift of life.
Kent says his wife Karen is a life saver. With her help, he uses a dialysis machine 2 hours a day, five days a week.
But ultimately his goal is to have a kidney transplant.
He says it’s a matter of life and death for him.
He's one of about 100 thousand people waiting for a kidney in the United States.
Kent is on a waiting list, after unsuccessfully finding a match within his family.
“They encouraged me to find my own living donor. Otherwise I'd have to wait 2-5 years for a cadaver to come up,” Kent explains.
That's when he realized he'd have to reach out to more people.
Kent hired an airplane to fly over the massive tailgating crowd before the Nebraska game.
The sign flown in the sky reads “Need kidney call 614-805-8466.”
“A tailgating scenario with a young crowd and alcohol, who knows what kind of calls I'm going to get. But all it takes is one,” Kent says.
He’s optimistic his phone number in the sky is the lifeline to his willing donor.
“There are living donors out there that don't know someone who needs a kidney, but they want to donate a kidney to somebody,” Kent says.
Thom already has big plans for his wife and granddaughter Amelia for when he's healthy. He plans to go to Disney World.
He says his insurance covers everything and there is no cost to the donor.
The Ohio State University performs more than 200 kidney transplants per year.
According to OSU's living kidney donor program:
- People able to donate are usually between 18 and 65-years-old
- Gender and race are not factors for a successful match
- The person should be good in overall physical and mental health.
For more information click here.
PKD Research
From BioPharmaDive.com
What is Autosomal Dominant Polycystic Kidney Disease?
Normal kidneys are fist-sized and weigh about a third of a pound. ADPKD patients develop cysts that cause the kidneys to enlarge over the course of decades. Renal enlargement leads to severe pain, increasing abdominal girth, hypertension, hematuria, kidney stones, and kidney infection. Many ADPKD patients develop end stage kidney disease (ESRD), which then requires either renal transplantation or dialysis. No medications can slow or stop the progression of ADPKD. Current treatments manage symptoms.
Developing a disease progression model for ADPKD
The lack of understanding of disease progression has hindered developing ADPKD treatments. Common renal function endpoints change late in the course of the disease. Thus, assessing the effectiveness of investigational drugs using these endpoints is difficult. Validating a biomarker that could predict disease progression earlier when patients are more likely to respond to medication was critical to enabling the development of treatments.
Certara Strategic Consulting won a bid to work with the C-Path Institute’s Polycystic Kidney Disease Outcomes Consortium to develop ADPKD disease progression models. The Consortium is a collaboration between C-Path, the PKD Foundation, Clinical Data Interchange Standards Consortium (CDISC), four academic medical centers, and three pharmaceutical companies. The consortium investigated Total Kidney Volume (TKV) as a prognostic biomarker for worsening kidney function and response to therapy in ADPKD patients.
Qualification of this novel biomarker involved multiple steps. First, data from patient registries and observational clinical trial data needed harmonization. To do this, C-Path worked with CDISC to create a data standard for ADPKD. Next, the data standard was used to remap the data into a single database. Then, Certara and the C-Path data management team curated the database for modeling. Finally, the data analysis and modeling strategies were discussed with the FDA pharmacometrics and biostats teams as well as clinicians to elucidate the role of age and glomerular filtration rate (eGFR) on the trajectory of TKV.
Model building and validation
Briefly, a key clinical outcome such as ESRD needed to be linked to the trajectory of TKV. Two additional endpoints were chosen— 30% and 57% worsening of renal function— since they occur in a shorter timeframe and predict the longer term outcome, ESRD. To identify potential confounding effects between the various predictors, Multivariate Cox models were used. Then, a simultaneous joint modeling framework of TKV and the time-to-event outcome was leveraged to account for TKV. A parametric survival submodel was used to simulate the probability of avoiding the clinical outcome according to a given baseline eGFR, TKV, and age. The final model was validated using a standard 5‑fold cross validation strategy.
The model will support ADPKD drug development in several ways. For example, it can simulate clinical trials to determine feasible trial durations. Likewise, the analysis results showed that longitudinal TKV, eGFR and age could predict the likelihood of developing the clinical outcome.
This complex project posed numerous challenges. For example, the database was continually updated. Thus, data analysis was an iterative process where outputs were generated as the dataset matured. Another challenge was finding a technology that facilitated working with busy clinicians. To obtain their critical input, they viewed project results via mobile devices that could be checked in the clinic. Certara’s technological infrastructure was indispensable to completing the project in record time.
Gaining regulatory support for a novel biomarker for ADPKD
In early 2015, the FDA issued a Biomarker Letter of Support for TKV. This biomarker will inform ADPKD clinical trial designs. Optimizing patient selection for clinical trials is an ethical imperative. It also increases the likelihood of the drug program’s success. Likewise, sponsors can use this biomarker to support regulatory decision making for drug development programs. The identification and validation of a prognostic biomarker for ADPKD should support developing new treatments that improve the lives of patients suffering from this devastating disease.
Walk for PKD
From CustomInk.com, Philadelphia, PA
"This is the second year the AECI Tigers are raising awareness on Polycystic Kidney Disease (PKD) among other charities we walk in to raise awareness. The event took place at the Pier 84 on a bright, crisp morning of Oct. 23. Working with CustomInk to produce all our school's t-shirts for charity event has been prompt and excellent quality. Thank you CustomInk!" - http://www.aecicharterhs.com/ - AECI Tigers (Nov 08, 2016)
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