Persistent secondary hyperparathyroidism in renal transplant recipients MedDRA version: 9.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary
Conditions
Interventions
Trade Name: ZEMPLAR
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Paricalcitol
Concentration unit: µg microgram(s)
Concentrati
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Concomitant administration of other forms of Vitamin D (different from paricalcitol ); - PTH 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate whether 6-months treatment with paricalcitol may achieve a prompt and effective reduction in PTH serum levels in stable renal transplant patients with secondary hyperparathyroidism.;Secondary Objective: To evaluate whether oral paricalcitol may also achieve a reduction in urinary protein excretion. Finally, the study will evaluate whether amelioration of hyperparathyroidism (if any) may translate into an improvement in markers of bone remodelling.;Primary end point(s): A PTH reduction during the 6 months of paricalcitol therapy (during both treatment periods) compared to the change in PTH levels during the corresponding 6 months without paricalcitol therapy. Therapy should target PTH values of 110 pg/mL or less, but higher than 60 pg/mL (to prevent the risk of adynamic bone disease). | — |
Countries
Italy
Outcome results
None listed