Are People With Chronic Kidney Disease Being Excluded From Clinical Trials and Access to New Therapies?

Major European and international kidney associations have joined in an awareness campaign to stress the urgent need to include patients with chronic kidney disease in clinical trials.

In a recent story covered by XTalks, we learned that people with chronic kidney disease (CKD) may not gain access to some of the newest drugs if they can’t be enrolled in a clinical trial. Until a drug has been tested on a CKD patient, doctors cannot assume its efficacy, and so patients seeking a new drug will have to wait.

An article in NEWS Medical Life Science reports that there are 850 million kidney patients worldwide (30 million in the U.S.) Both articles concur that because CKD patients are not always included in clinical trials, many patients in needs will not receive the benefit of novel therapies.

CKD as a Risk Factor

Studies show CKD as being a risk factor for (as well as being a product of) cardiovascular disease, diabetes, and various cancers. Mild kidney problems tend to worsen over time. Waste and fluid accumulate in the blood and segue into other diseases. This brings up another critical issue. If a new drug is not tested on CKD patients, then doctors cannot rely on the drug to be effective.

Therefore it is of vital importance that CKD patients be included in trials so that they will be eligible to receive new treatments for liver disease, cardiovascular disease, diabetes, and various cancers.

New Treatments are Not Reaching CKD Patients

The President of the European Renal Association said that innovative treatments are not reaching CKD patients. She points to newly developed antidiabetic drugs designed to guard kidney function. But to date, eligible CKD patients have not been tested with the drugs. That means that these patients will be unable to access medication that can slow the progression of CKD.

FDA’s Kidney Health Initiative

The Kidney Health Initiative is composed of industry leaders, scientists, clinical professionals, FDA members, and CKD patients. The group’s mission is to identify barriers that prevent CKD patients from being selected for clinical trials. Strategies are discussed that are designed to encourage CKD patients’ acceptance into clinical trials. The project is set to end in mid-2019.

The FDA has prepared and released its briefing document setting out the need to have more CKD patients enter clinical trials. It also explains how kidney function affects the way in which drugs are metabolized. The briefing document emphasizes the need for stand-alone dosing studies that are conducted with the intent of identifying the proper dosage for patients with various levels of kidney disease.

But these stand-alone studies cannot be considered a substitute for the original clinical trials with respect to efficacy and safety data. In cases of severe renal disorder, the drug must be analyzed for absorption, distribution, metabolism, and excretion.

The Road Ahead

The U.S. Government agrees that kidney disease is a problem in the United States and worldwide. The government’s approach to improving conditions in the U.S. includes increasing research and preventative measures, providing more affordable dialysis, and working to increase living kidney donors.


Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia four years ago. He was treated with a methylating agent While he was being treated with a hypomethylating agent, Rose researched investigational drugs being developed to treat relapsed/refractory AML.

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