A PROSPECTIVE, PILOT, CROSS-OVER STUDY TO ASSESS THE EFFICACY OF PARICALCITOL IN REDUCING PARATHYROID HORMONE LEVELS AND AMELIORATING MARKERS OF BONE REMODELLING IN RENAL TRANSPLANT RECIPIENTS WITH SECONDARY HYPERPARATHYROIDISM (APPLE STUDY) - ND

Phase 1

• Conditions: Persistent secondary hyperparathyroidism in renal transplant recipients; MedDRA version: 9.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary

• Registration Number: EUCTR2008-006380-36-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-11-06
• Study Completion: 2012-07-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 42

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).