Status:
COMPLETED
Paricalcitol in Reducing Parathyroid Hormone Levels and Ameliorating Markers of Bone Remodelling in Renal Transplant Recipients With Secondary Hyperparathyroidism
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Conditions:
Renal Transplant
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 al...
Detailed Description
BACKGROUND The risk of fracture for kidney transplant recipients is 4 times higher that of the general population. The pathogenesis of post-transplant bone disease is multifactorial, but hyperparathyr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01220050
Start Date
September 1 2009
End Date
February 1 2013
Last Update
February 22 2013
Active Locations (1)
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1
Mario Negri Institute - Clinical Research Center for Rare Diseases
Ranica, Bergamo, Italy, 24020