Secondary Hyperparathyroidism Clinical Trial
— APPLEOfficial title:
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
The risk of fracture for kidney transplant recipients is 4 times higher that of the general
population. The hyperparathyroidism plays a key role in the maintenance or development of
post-transplant alterations of bone remodelling.
Renal transplant patients are at high risk of hyperparathyroidism, largely because of
long-lasting renal insufficiency before transplant, and of progressive deterioration of
kidney function because of chronic allograft nephropathy (a disease of proteinuria and
progressive decline of the glomerular filtration rate).In hemodialysis patients, intravenous
paricalcitol (19-nor-1,25-dihydroxyvitamin D2), a new vitamin D analogue, achieves a faster
and more effective normalization of parathyroid hormone (PTH) levels than calcitriol
(1,25-dihydroxyvitamin D3), an effect that is associated with smaller changes in serum
calcium and phosphorus levels.
Whether oral paricalcitol may help achieving a prompt reduction in serum PTH levels and,
secondarily, in urinary protein excretion in renal transplant recipients with secondary
hyperparathyroidism is worth investigating.
Status | Completed |
Enrollment | 43 |
Est. completion date | February 2013 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Mario Negri Institute - Clinical Research Center for Rare Diseases | Ranica | Bergamo |
Lead Sponsor | Collaborator |
---|---|
Mario Negri Institute for Pharmacological Research |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Every three months. | No | |
Secondary | Measurement of osteocalcin. | Baseline and then every three months. | No | |
Secondary | Measurement of bone alkaline phosphatase. | Baseline and then every three months. | No | |
Secondary | Measurement of urinary deoxypyridinoline. | Baseline and then every three months. | No | |
Secondary | Bone mineral density (by MOC). | At baseline and at the end of both treatment periods. | No |
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