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:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT01768351
Eligibility Criteria:
Inclusion criteria:
* age \> 18
* written informed consent
* CKD stage 3-5 (eGFR \<60 ml/min/1,73 m2)
* PTH 30-300 pg/ml
* Hb \<10 g/dl \>3 consecutive months
* Ferritin \> 100 ng/ml
* transferrin saturation (TSAT) 20-40%
* mean corpuscular volume (MCV) 85-95%
* for patients treated with Ace-inhibitors or angiotensin receptor blockers, dose stable \>3 months
* for patients treated with erythropoiesis-stimulating agents (ESA), dose stable \>3 months
Exclusion criteria:
* anemia due to non renal cause
* presence of malignancies, inflammatory or infectious disease \>3 months
* pregnancy
* bleeding \>6 months
* C-reactive protein (CRP) \>1 mg/dl
* poorly controlled hypertension (PAS \> 170 mmHG and PAD \>100 mmHg)
* severe malnutrition
* hypercalcemia (\>10,5 mg/dl)
* hyperphosphatemia (\>5,5 mg/dl)
* surgical interventions \>3 months
* acute myocardial infarction, unstable angina, stroke or transitory ischemic attack, deep venous or pulmonary thromboembolism, congestive heart failure \>3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01768351
Study Brief:
Protocol Section:
NCT01768351