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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT01820832
Eligibility Criteria:
Inclusion Criteria:
* aged 18-75 years
* clinical diagnosed and/or biopsy-confirmed primary glomerulonephritis
* proteinuria 0.15-1.0 g/d in 2 consecutive samples within 4 weeks despite ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) treatment for at least 1 year or ACEI/ARB withdrawal because of of drug intolerances (low blood pressure, cough, hyperkalemia) for at least 1 month
* estimated glomerular filtration rate (eGFR)\>60ml/min/1/73m2
* corticosteroid and immunosuppressive agents withdrawal for at least 6 months
* normal blood pressure
* serum intact parathyroid hormone (iPTH) level \>20pg/mL
* corrected serum calcium level \< or = 2.55 mmol/L
* serum phosphorus level \< or = 1.68 mmol/L
* 24 hours urinary calcium excretion level \< or = 7.5 mmol
* not receive treatment of vitamin D or its analogue within 6 months
* willigness to give written consent and comply with the study protocol
Exclusion Criteria:
* history of sensitivity or allergy to calcitriol or other vitamin D analogs
* pregnancy, lactating women
* history of severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
* history of malignancy
* history of extraskeletal calcification, hyperuricemia, gout, kidney stone, gall stone, bone diseases
* patients receiving drugs contains of calcium
* patients receiving cimetidine, trimethoprim, or other drugs which can increase tubular creatinine reabsorption
* participation in any other trials within 1 month
* history of non-compliance
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01820832
Study Brief:
Protocol Section:
NCT01820832