Research-based therapies put patients first

The doctors and researchers at the Renal Research Institute and our academic partners are always working on investigating new areas with the aim of helping patients feel better and live longer.

So we’re always learning. The patients at our Avantus Renal Therapy clinics very frequently have the opportunity to enroll in studies which the Renal Research Institute either initiates or is a participating center. In this way, you have an opportunity to be part of clinical studies that focus on ways to improve patient care. Physicians and their patients together can decide in which studies they wish to participate, or none at all, if they choose.

For our patients and our staff, it’s exciting to be involved with an organization on the cutting edge of developing renal therapies and best practices. Our patients have taken part in every relevant National Institute of Health (NIH) study. With over three-hundred publications authored and numerous research achievements attained, the Renal Research Institute has led on every front — clinical research efforts on improving mortality rates, vascular access survivability, improving quality of life, enhancing dialysis technology, and progressive therapies for at-home and in-clinic use.

Current research efforts at RRI focus on enhancing patient outcomes by reducing bacteria and bacteria-products that enter the blood during dialysis. To that end, scientists and engineers are leading the industry in an approach for water purification that will tests to the highest standards of water purity – ultrapure water.

This is another example of the Avantus Renal Therapy commitment to the highest standard of patient care. It’s one more thing our patients and their doctors can feel good about.

A common theme of much of the research performed by RRI is the improvement of outcomes. These can be grouped as:

• Those improving mortality rates which is closely related to reduction in hospitalization
• Improvement of quality of life particularly in relationship to the dialysis treatment
• Improvement in the success of vascular accesses by prolongation of their survival and reduction in their complication rates
• Improvement in the understanding of events that occur prior to death or hospitalization with the aim of establishing programs which will favorably reduce the rate or effect of such events
• Development of new technology which will provide an early warning of clinical problems

For a complete list of overall areas of research achievement, See below:

Scholarly reviews

• Iron and anemia
• Methods for measurement of body composition and measurement of excess water so that we know how much to remove with every treatment
• On-line clearance in hemodialysis to indicate with every dialysis how efficiently the dialyzer is working to remove poisons from the body
• Phosphate removal in hemodialysis
• Calcium balance

Vit C:

• Deficiency in dialysis patients
• Role in anemia and iron metabolism
• Role in hyperphosphatemia

Bioimpedance:

• First comprehensive correlation with gold standard
• Body composition Techniques with bioimpedance
• Development of first independent dry weight monitor
• Potential use of bioimpedance to investigate ultrafiltration failure in PD
• Studies of overhydration in hydration in CKD

Nutrition:

• Significance of albumin levels
• Diagnosis of malnutrition
• Interplay with inflammation
• Salt and its role in chronic kidney disease

Anemia

• First study of Venofer IV iron
• Response to erythropoeisis and a variety of clinical studies
• Red cell life span

Cardiovascular studies

• Measurement of cardiac output in dialysis patients
• Statin use
• International differences in CV mortality in dialysis patients
• Cardiovascular calcium in CKD
• Modifiable risk factors for cardiovascular disease
• Effect of calcium and phosphorus on cardiac outcomes
• Hypotensive and blood volume control

Inflammation

• Periodontal disease
• Albumin levels
• Role of Intestinal bacterial microflora
• Erythropoetin requirements
• Relationship of CRP and IL-6 to cardiovascular risk factors
• Immunomodulating effects of Vit D
• Water quality and inflammation
• Measurement of iosprostanes and of breath ethane as indication of inflammation

Uremic Toxins

• Sorbents in acute and chronic kidney failure
• Sorbents and inflammatory markers
• B2Microglobulin and outcomes
• Effect of high flux dialysis
• Hemodialfiltration
• Role of middle molecules

Dialysis Technology

• New catheters
• Sorbent technology
• Dialysis dose and outcome
• Slow continuous intracorporeal plamsmaphorese
• Online monitoring of cerebral hemodynamics
• Dialysis membranes for CRRT
• Flow distribution and cross filtration in dialyzer
• Sorbent devices for removal
• Development of the blood temperature monitor
• Dialyzer reuse – a new method using heat and citric acid
• Continuous flow peritoneal dialysis
• High flux dialysis and lipid control

DOQI /KDOQI/KDIGO: The RRI was heavily involved in the initial guidelines produced in the USA and internationally in these important organizations.

Vascular Access: RRI pioneered a subcutaneous vascular access which permitted use of chronic catherization of the internal jugular vein without the risk of infection occurring so often with current catheters with which are exposed to the environment. This novel device improved the quality of life of patients as well as prolonging the period of functionality of the catheter. Unfortunately the company supporting this research failed with no subsequent development.

Other advances evaluated by RRI were methods for the measurement of recirculation by use of the blood temperature monitor and of clinical trial investigating the value of regular measurements of vascular access flow on the need and success for operative or international radiological investigations.

Association of various types of vascular access with the presence of inflammation and sensitivity to erythropoeitic agents have resulted in a search for methods of controlling “biofilm” the conglomeration of various bacterial species which lines catheters and other vascular accesses and causes widespread inflammation in the body and resistatnce to effectiveness

Vitamin Studies
Vitamin C
RRI has pioneered in investigating the frequency of low Vit C concentrations in dialysis patients (sometimes to levels seen in scurvy levels.) The association of Vit C with anemia, particularly in relationship to availability of iron for red cell production has been examined from several points of view.

Vitamin D
The relationship of the time of administration of a commonly prescribed Vitamin D analogue during the dialysis treatment to markers of inflammation has been systematically studied.

Answers to several Frequently Asked Questions:

What is a clinical trial?
Clinical trials are scientific studies in which new treatments — drugs, diagnostic procedures, and other therapies — are tested in patients to determine if they are safe and effective. Such trials help scientists answer a variety of questions about new therapies: what diseases should they be used for? What doses of new drugs are most effective? And which patients can benefit the most from them? Nearly all cancer drugs in use today were tested and made available to patients through clinical trials.

Who can participate in a clinical trial?
To qualify for a particular study, patients must meet a carefully defined set of criteria. Those criteria usually relate to patients' age and gender, the type and severity of their condition, and the types of treatments they have already received.

Where do clinical trials take place?
In the dialysis units or in some instances patients volunteer for tests outside the facility.

What information do patients receive about
clinical trials?
Patients interested in participating in a clinical trial are informed in advance about the possible risks and benefits of the therapy being studied, and their written consent is obtained before treatment begins. As the trial progresses, participants are given new information that may affect their willingness to stay in the trial. Participants may withdraw from the trial at any time.

How are patients protected?
Before any clinical trial begins, it must be approved by its host institution's Institutional Review Board (IRB), which includes researchers and physicians. The IRB considers whether proposed studies are safe and well planned and whether they will ultimately advance patient care. It also reviews studies to ensure patients are adequately informed about the risks of participating in clinical research. In all studies, the health of each patient is closely monitored during the course of the trial.

What are the rules by which clinical trials proceed?
The rules, known as clinical protocols, vary from study to study. In general, they deal with a study's design, who can participate, and the kind of information people must be given before agreeing to enroll. Every trial has a principal investigator, usually a physician, Is responsible for the performance of the trial.


Adapted from information published by the National Cancer Institute.

The doctors and researchers at the Renal Research Institute and our academic partners are always working on something interesting, always looking for something new that will help patients feel better, or live longer. So we’re always learning. And the patients at our Avantus Renal Therapy clinics very frequently have the opportunity to enroll in studies which the Renal Research Institute either initiates or is a participating center.

In this way, you have an opportunity to be part of clinical studies that focus on ways to improve patient care. Physicians and their patients together can decide in which studies they wish to participate, or none at all, if they choose.