Status:
COMPLETED
Efficacy and Safety of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
Abbott
Conditions:
Disorder of Transplanted Kidney
Proteinuria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 prot...
Detailed Description
Kidney transplantation is the treatment of choice for end-stage renal disease patients. In comparison to dialysis it offers longer survival and better quality of life to certain patients with end stag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01436747
Start Date
July 1 2012
End Date
July 1 2015
Last Update
December 27 2017
Active Locations (1)
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1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000