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

NCT01220050 | Completed Phase 2

• 2 other identifiers: APPLE2008-006380-36
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Renal Transplant; Secondary Hyperparathyroidism

Keywords

Paricalcitol; Renal transplant; Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Measurement of osteocalcin.

  Baseline and then every three months.

• Measurement of bone alkaline phosphatase.

  Baseline and then every three months.

• Measurement of urinary deoxypyridinoline.

  Baseline and then every three months.

• Bone mineral density (by MOC).

  At baseline and at the end of both treatment periods.

Study Arms (2)

Paricalcitol

EXPERIMENTAL

Drug: Paricalcitol

Standard therapy

ACTIVE COMPARATOR

Drug: Standard therapy

Interventions

Paricalcitol DRUG

Paricalcitol capsules 1- 2 mcg/day/pts for 26 weeks

Paricalcitol

Standard therapy DRUG

Standard therapy for hyperparathyroidism for 26 weeks

Standard therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Mario Negri Institute - Clinical Research Center for Rare Diseases

Ranica, Bergamo, 24020, Italy

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

paricalcitol; Standard of Care

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: September 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: February 1, 2013
• Last Updated: February 22, 2013

Record last verified: 2013-02

Locations

IT (1)