Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT02469467
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent given
* Able to comply with the study procedures and medications
* On a stable hemodialysis (HD) regimen (3 times per week) including hemodialysis and hemodiafiltration for ≥12 weeks at screening and during the study period
* No change in prescribed dose or frequency of any of the following medications within 4 weeks prior to screening
1. Injectable iron agents
2. Oral or injectable active vitamin D3
3. Oral nutritional vitamin D
4. Calcimimetics
5. Calcium supplements
6. Anti-osteoporotic medication including bisphosphonates
7. Calcitonins
* Must be willing to avoid intentional changes in diet throughout the study
* Women of child-bearing potential or non-sterile male subjects and those who are sexually active with a non-sterile female partner must agree to use highly effective contraception
* Plasma Pi level \>1.94 mmol/L (6.0 mg/dL) to \<3.23 mmol/L (10.0 mg/dL) after 2 weeks washout will qualify patients to enter the treatment period
Exclusion Criteria:
* Blood purification therapy other than HD (hemodialysis and hemodiafiltration)
* The plasma Pi level is \>2.26 mmol/L (7.0 mg/dL) within the latest three tests prior to screening.
* Variation of the plasma Pi is over 0.65 mmol/L (2.0 mg/dL) within the latest three tests prior to screening.
* Pre-emptive or scheduled renal transplant
* History of hemochromatosis or ferritin ≥1000 mcg/L
* Oral iron agents including prescribed and over-the-counter drugs at screening.
* Current clinically significant gastrointestinal (GI) disorder, including GI bleeding, colitis, inflammatory bowel disease, irritable bowel syndrome, chronic constipation, new diagnosis of peptic or duodenal ulcer disease, within 4 weeks prior to screening
* History of gastrectomy or duodenectomy, or GI tract surgery within 12 weeks prior to screening
* Hypertension: Defined using pre-dialysis vital of diastolic blood pressure \>110 mmHg or systolic blood pressure \>180 mmHg
* Possible parathyroid intervention including surgical parathyroidectomy and percutaneous ethanol injection therapy during the study period
* Clinical evidence of active malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous carcinoma of the skin
* Severe cardiovascular disorders such as recent myocardial infarction; unstable angina; congested heart failure (NYHA class II or above) hospitalized within 24 weeks (6 months), valve stenosis, atrial fibrillation and arrhythmia
* History of event by cerebrovascular disease or cardiovascular disease within 24 weeks (6 months) prior to screening
* Active infection or current treatment with antibiotics within 2 weeks prior to screening
* History of HIV (ELISA and Western blot) test results
* Known active liver disease with aspartate aminotransferase or alanine aminotransferase levels greater than x3 the upper limit of normal
* Hepatitis B and/or hepatitis C treated with antiviral treatment within 4 weeks prior to screening
* History of allergy of VS-505 and its related components
* Receipt of any investigational drug within 4 weeks prior to screening
* Pregnant and breast-feeding women
* Other patients who in the opinion of the investigators are ineligible for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02469467
Study Brief:
Protocol Section:
NCT02469467