What are clinical trials?

Clinical trials are studies involving drugs or devices managed or sponsored by government agencies (such as National Institutes of Health), educational institutions, not-for-profit organizations or commercial groups that develop, produce and/or evaluate effectiveness of new drug or device therapies.

How are clinical trials conducted?

Clinical trials are strictly conducted under the regulatory oversight of bodies such as Institutional Sponsoring Agency, Review Boards (IRB), Data Safety Monitoring Board (DSMB) and/or Food and Drug Administration (FDA).

There are several processes in place designed to protect the potential participants that include:

• Informed Consent: The process of providing subjects with detailed information about important information specific to the clinical trial and about the experimental drug or device that may be involved in it.
• Sponsoring Agency: Ensures through rigorous protocol and periodic review that potential participants are adequately protected.
• Institutional Review Board (IRB): The IRB is responsible for instituting strict oversight of the clinical trial with the goal of protecting the rights and well-being of people who participate in research studies. Most clinical research studies cannot begin without a review board‘s approval. Board members generally include health care personnel such as doctors, nurses, and pharmacists. The Board also includes other members of the scientific community, non-scientists such as clergy or social workers, and community members.

What are the phases of Clinical Trials?

• Phase I Trial: These are studies to assess how a drug should be administered, how often and what is the dosage.Such trials focus on the safety of the drug agent.
• Phase II Trial: Provide preliminary information on how a therapy works and regarding its safety and benefits.
• Phase III Trial: The aim is to compare the new therapy, procedure or device with current standard.
• Phase IV Trial: Includes ongoing evaluation of the drug or device after it has been approved by the FDA and has become available for general use.

What is a Clinical Trial Protocol?

Clinical Trial Protocols are a set of sepcific and stringent set of guidelines that must be followed throughout the course of study. These guidelines include:

• Study Design
• Eligibility criteria: who can participate in study
• Treatment and medical tests to be followed during the course of study
• Specific study related questions that trial may be seeking to answer

Who can participate in a clinical trial?

Participation in a clinical trial is defined by eligibility criteria. The particpants must meet these criteria in order to be eligible to particpate in the trial. Having appropriate eligibility criteria assures that the results answer the questions study was desinged for and also determines who is likely to benefit from the researched drug, procedure or device.

Eligible participants will receive at no cost; study medications, blood pressure checks, study related physical exams, lab testing and electrocardiograms. Compensation for time and travel is available for qualified individuals.

non-dialysis patients for a gout study

• An additional study medication to your existing allopurinol or Uloric (febuxostat)
• Status: Now Screening
• Request for more information on this trial

Soon to be dialysis or catheter only patients for fistula placement

• Less than 12 month on dialysis Collagen medicated wrap to help new fistula heal faster, less scarring, etc.
• Status: Now Screening
• Request for more information on this trial

VERY NEW to dialysis for anemia

• Less than 90 days on dialysis
• Oral medication for treatment of anemia
• Status: Now Screening
• Request for more information on this trial

Non-dialysis metabolic acidosis

• OOral medication for treatment of metabolic acidosis
• Status: Now Screening
• Request for more information on this trial

Dialysis patients with high phosphorus (hyperphosphatemia)

• Oral medication for treatment of hyperphosphatemia
• Status: Now Screening
• Request for more information on this trial

Dialysis patients who have NOT had a hepatitis B vaccine

• New hepatitis B vaccine
• Status: Now Screening
• Request for more information on this trial

Non-dialysis anemia – not taking injections

• New oral medication for treatment of anemia
• Status: Now Screening
• Request for more information on this trial

Anemia in Chronic Kidney Disease

• Oral tablets to help treat Anemia in individuals
• Status: Now Screening
• Request for more information on this trial

Anemia in Chronic Kidney Disease

• Oral tablets vs. Injection to help treat Anemia in individuals
• Status: Now Screening
• Request for more information on this trial

Anemia in Chronic Kidney Disease in Individuals On Dialysis

• Oral tablets to help treat Anemia in individuals
• Status: Now Screening
• Request for more information on this trial

Diabetic Chronic Kidney Disease with Protein in Urine

• Individuals with Diabetic Chronic Kidney Disease leading to protein in urine
• Currently two studies patients may qualify for
• Status: Now Screening
• Request for more information on this trial

Patients Initiating Hemodialysis who are ≥ 50 years old

• Wearable Cardio-defibrillator to protect against sudden cardiac death
• Status: Now Screening
• Request for more information

Sponsors

CROs