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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT01220050
Eligibility Criteria:
Inclusion Criteria:
* Males and females \>18 years old
* Renal transplant recipients with persistent secondary hyperparathyroidism
* PTH persistently \>80 pg/mL up 2 month post transplant (stable or progressively increasing PTH levels)
* No ongoing therapy with Vitamin D
* Patients on maintenance therapy with calcineurin inhibitors and Mycophenolate Mofetil or Azathioprine
* Serum creatinine \< 2mg/dL
* Patients legally able to give written informed consent to the trial (signed and dated by the patient)
* Written informed consent.
Exclusion Criteria:
* Concomitant administration of other forms of Vitamin D (different from paricalcitol)
* PTH\< 80 pg/ml
* Serum Ca\> 10,2 mg/dL
* Clinically serious condition
* History of malignancy
* Evidence of active hepatitis C virus, hepatitis B virus or human acquired immunodeficiency virus infection
* Specific contraindications or history of hypersensitivity to the study drugs;
* Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer
* Drug or alcohol abuse
* Any chronic clinical conditions that may affect completion of the trial or confound data interpretation
* Pregnancy or lactating
* Women of childbearing potential without following a scientifically accepted form of contraception
* Legal incapacity
* Evidence of an uncooperative attitude
* Any evidence that patient will not be able to complete the trial follow-up.
* Previous diagnosis of: intellectual disability/mental retardation, dementia, schizophrenia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01220050
Study Brief:
Protocol Section:
NCT01220050