Efficacy and Safety of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The study 'Safety and Efficacy of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients' is designed to assess the effects of paricalcitol in kidney transplant recipients with proteinuria.

It is a single centre, randomized, placebo-controlled, double-blind clinical trial that tests the hypothesis that 24 weeks' treatment with paricalcitol compared to placebo will result in a decrease in urinary protein excretion in recipients of a kidney transplant at least three months after transplantation. Additionally, the effects of paricalcitol on albuminuria, estimated glomerular filtration rate, and blood pressure will be investigated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Collaborator: Abbott
• Treatments: Ergocalciferols; Vitamin D

Criteria

Inclusion Criteria:

• Recipients of a deceased donor kidney transplant at least 3 months after transplantation

• Urinary protein to creatinine ratio (UPCR) > 200 mg/g (20 mg/mmol) as determined by the the mean of three second morning void urine specimens

• Subject is on stable immunosuppression for at least 3 months

• Subject is on stable doses of antihypertensive medications for at least 3 months

• Subject is not expected to begin dialysis for at least 6 months

• Estimated glomerular filtration rate > 15 ml/min/1.73 m2

• Corrected serum calcium level < 2.6 mmol/l

• Intact parathormone value > 30 pg/ml

Exclusion Criteria:

• Subjects on vitamin D receptor activation therapy within 3 months prior to the first study visit

• Acute kidney injury within 3 months of the first study visit

• Subjects with poorly controlled hypertension