BridgeMD
New treatment option for Chronic Kidney Disease
Official title Renal Impairment Study for Oral EC5026
ClinicalTrials.gov ID: NCT07694544
What this study is testing
What is EC5026 oral tablet?
EC5026 oral tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic kidney disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this Phase 1 clinical trial is to assess single dose pharmacokinetics of oral EC5026 in a population with chronic kidney disease. The main questions it aims to answer are: 1.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older. Healthy volunteers may be eligible.
You may be able to join if
- Each study participant must meet all of the following criteria to be enrolled in this study:
- Male and female participants must be 55 and older.
- Study participants must be willing and able to provide written informed consent to participate in the study.
- Participants with CKD must be stage 3b-5 (estimated glomerular filtration rate (eGFR) ≤ 44 ml/min per 1.73m2) without dialysis. Control participants...
- Aside from the diagnosis of CKD, study participants must be in overall stable condition, as determined by pre-study medical history, physical...
You likely can't join if
- must be on stable doses of medications for at least 30 days prior to enrollment. Doses should be expected to remain stable for the duration of the...
- Male participants must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
- Male participants must use, from enrollment until at least 2 months after the last dose, a highly effective contraception method (less than 1...
- Female participants must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal...
- Participants who have donated and/or received any blood or blood products (more than 450 mL) within 3 months prior to enrollment.
- Participants who have used any other investigational drug within 1 month prior to Screening. If the investigational drug is known to have a long...
See the full eligibility criteria
Who can join
- Each study participant must meet all of the following criteria to be enrolled in this study:
- Male and female participants must be 55 and older.
- Study participants must be willing and able to provide written informed consent to participate in the study.
- Participants with CKD must be stage 3b-5 (estimated glomerular filtration rate (eGFR) ≤ 44 ml/min per 1.73m2) without dialysis. Control participants must have an eGFR of ≥90 ml/min per 1.73m2.
- Aside from the diagnosis of CKD, study participants must be in overall stable condition, as determined by pre-study medical history, physical examination, clinical laboratory tests, and 12-lead ECG measurements.
- Study participants must have a body mass index (BMI) of 19-40 kg/m2. Participants with a BMI below 19 kg/m2 may be enrolled at the Investigator's discretion.
- Study participants must have a systolic blood pressure (BP) of 90-170 mmHg, diastolic BP of 50-90 mmHg, and resting HR of 40-100 beats per min at Screening, with or without stable doses of anti-hypertensive medication.
- Study participants must be non-smokers or previous smokers who have not smoked within the previous 6 months prior to Screening.
- Participants taking non-study medications not explicitly listed in the
What rules you out
- must be on stable doses of medications for at least 30 days prior to enrollment. Doses should be expected to remain stable for the duration of the study. Standard of care medications for the CKD population which will be...
- Male participants must not donate sperm during the study and for 12 months after receiving the last dose of study drug.
- Male participants must use, from enrollment until at least 2 months after the last dose, a highly effective contraception method (less than 1 pregnancy per 100 people using the method for one year), e.g.: sterilization...
- Female participants must be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, or surgically sterile (bilateral tubal ligation ('clipping or tying tubes' or hysterectomy) for at least 3 months...
- Participants who have donated and/or received any blood or blood products (more than 450 mL) within 3 months prior to enrollment.
- Participants who have used any other investigational drug within 1 month prior to Screening. If the investigational drug is known to have a long half-life, a longer washout period will be done.
- Participants using opioid medications on a regular basis or pro re nata (PRN). Non-opioid pain medications will be allowed if at a fixed stable dose for more than 1 month prior to Screening with no anticipation of the...
- Participants who have used (within 30 days of enrollment) or plan on using during the duration of the study any prescription or over-the-counter drugs that are cytochrome P450 3A4 (CYP3A4) inducers or inhibitors (e.g...
- Participants who have used (within 30 days of enrollment) or plan on using during the duration of the study any dietary aids, supplements, or foods that are known to modulate drug metabolizing enzymes (e.g., St. John's...
- Participants with difficulty in swallowing oral medications.
- Participants who have active cancer or have a high risk of cancer recurrence requiring active surveillance. Participants with a personal history of cancer or metastatic cancer in first degree relatives suggestive of...
- Participants with a history of disorders of the hypothalamic-pituitary-adrenal or hypothalamic-pituitary-gonadal axis
- Participants with a presence or history of active gastrointestinal disorder, including esophageal or gastroduodenal ulceration, or hepatic, or coagulant disorder within 1 month prior to enrollment
- Participants with any clinically unstable cardiovascular (including acute coronary syndrome within the 6 months prior to Screening), respiratory, hematological, endocrine disorder, as determined by the study physician.
- Participants with severe systolic heart failure (Ejection Fraction \<35%).
- Participants with exercise-limiting cardiopulmonary disease including severe valvular heart disease, exertional angina, and/or major atherosclerotic cardiovascular event within last 6 months.
- Participants with a history of unstable arrhythmia.
- Participants with clinically significant and persistent electrolyte abnormalities including hypokalemia (K\ 5.4mEq/dL).
- Participants with serious psychosocial comorbidities as determined by the Investigator.
- Participants with current cognitive or major psychiatric disorders, or any other condition that could interfere with compliance with study procedures.
- Participants with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to enrollment.
- Participants with confirmed COVID-19, or suspected COVID-19 (e.g., developed symptoms of a respiratory infection such as cough, sore throat, shortness of breath, or fever, but did not get tested for COVID-19) at the...
- Participants with confirmed moderate-severe COVID-19 within 2 months of enrollment or with confirmed asymptomatic or mild COVID-19 within 4 weeks of enrollment.
- Participants who have received a COVID-19 vaccine within 4 weeks of enrollment or are planning on receiving it during the study duration.
- Participants with medical history of active Hepatitis A, Hepatitis B, Hepatitis C, and/or HIV.
- Participants with a positive drug or alcohol test during Screening and/or admission (a positive THC test will be allowed as long as it consists of minimal social use, per discretion of Investigator).
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.