Efficacy and Safety of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients
This study is currently recruiting participants.
Verified September 2012 by University Medical Centre Ljubljana
Sponsor:
University Medical Centre Ljubljana
Collaborator:
Abbott
Information provided by (Responsible Party):
Miha Arnol, M.D., Ph.D., University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01436747
First received: September 14, 2011
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Disorder of Transplanted Kidney Proteinuria Albuminuria |
Drug: Paricalcitol Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of Selective Vitamin D Receptor Activation With Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients: a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by University Medical Centre Ljubljana:
Primary Outcome Measures:
- The percentage change in urinary protein to creatinine ratio (UPCR) from baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The percentage change in urinary albumin to creatinine ratio (UACR) from baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- The percentage change in 24-hour urinary protein excretion form baseline to the last measurement during treatment. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- The proportion of patients achieving at least a 15% reduction in the last on-treatment UPCR level from the baseline. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]
- Change in estimated glomerular filtration rate, blood pressure and biomarkers, including (but not limited to) C-reactive protein, plasma renin activity, aldosterone. [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 166 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Paricalcitol |
Drug: Paricalcitol
2 micrograms daily, peroral, 24 weeks
Other Name: Zemplar
|
| Placebo Comparator: Matching placebo |
Drug: Placebo
2 micrograms daily, peroral, 24 weeks
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 (22 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 <= 2.5 mmol/l
- Intact parathormone value > 35 pg/ml
Exclusion Criteria:
- Subjects on vitamin D receptor activation therapy within 3 months prior to the first study visit
- Diagnosis of primary focal segmental glomerulosclerosis (FSGS)
- Acute kidney injury within 3 months of the first study visit
- Subjects with poorly controlled hypertension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436747
Contacts
| Contact: Miha Arnol, M.D., Ph.D. | +386 1 522 8977 | miha.arnol@mf.uni-lj.si |
| Contact: Aljoša Kandus, M.D., Ph.D. | +386 1 522 2978 | aljosa.kandus@kclj.si |
Locations
| Slovenia | |
| University Medical Centre Ljubljana | Recruiting |
| Ljubljana, Slovenia, 1000 | |
| Contact: Miha Arnol, M.D., Ph.D. +386 1 522 8977 miha.arnol@mf.uni-lj.si | |
| Contact: Aljosa Kandus, M.D., Ph.D. +386 1 522 2978 aljosa.kandus@kclj.si | |
| Principal Investigator: Miha Arnol, M.D., Ph.D. | |
| Sub-Investigator: Manca Oblak, M.D. | |
| Sub-Investigator: Gregor Mlinsek, M.D., Ph.D. | |
| Sub-Investigator: Jadranka Buturović-Ponikvar, M.D., Ph.D. | |
| Sub-Investigator: Aljosa Kandus, M.D., Ph.D. | |
Sponsors and Collaborators
University Medical Centre Ljubljana
Abbott
Investigators
| Principal Investigator: | Miha Arnol, M.D., Ph.D. | University Medical Centre Ljubljana, Department of Nephrology |
| Study Chair: | Aljoša Kandus, M.D., Ph.D. | University Medical Centre Ljubljana, Department of Nephrology |
More Information
No publications provided
| Responsible Party: | Miha Arnol, M.D., Ph.D., University Medical Centre Ljubljana |
| ClinicalTrials.gov Identifier: | NCT01436747 History of Changes |
| Other Study ID Numbers: | 31-06-2011 |
| Study First Received: | September 14, 2011 |
| Last Updated: | September 5, 2012 |
| Health Authority: | Slovenia: Agency for Medicinal Products - Ministry of Health Slovenia: Ethics Committee |
Keywords provided by University Medical Centre Ljubljana:
|
Kidney transplantation Proteinuria Albuminuria Vitamin D Paricalcitol |
Additional relevant MeSH terms:
|
Albuminuria Proteinuria Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Ergocalciferols |
Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013