Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Treatments: Ergocalciferols; Hormones

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.