Paricalcitol versus placebo for reduction of proteinuria in kidney transplant recipients: a double-blind, randomized controlled trial
| Autor: | Manca Oblak, Jadranka Buturović-Ponikvar, Aljoša Kandus, Gregor Mlinšek, Miha Arnol |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Paricalcitol medicine.medical_specialty Randomization Urinary system 030232 urology & nephrology Urology Angiotensin-Converting Enzyme Inhibitors 030230 surgery Kidney Function Tests Placebo law.invention Cohort Studies Renin-Angiotensin System 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law medicine Albuminuria Humans Renal Insufficiency Kidney transplantation Aged Transplantation Proteinuria Intention-to-treat analysis Bone Density Conservation Agents business.industry Graft Survival Middle Aged medicine.disease Kidney Transplantation Phenotype Treatment Outcome Creatinine Ergocalciferols Female medicine.symptom business medicine.drug |
| Zdroj: | Transplant International. 31:1391-1404 |
| ISSN: | 0934-0874 |
| DOI: | 10.1111/tri.13323 |
| Popis: | Proteinuria after kidney transplantation is accompanied by an increased risk of graft failure. In this single-center, placebo-controlled, double-blind trial we studied whether vitamin D receptor activator paricalcitol might reduce proteinuria. Patients with urinary protein-to-creatinine ratio (UPCR) ≥20 mg/mmol despite optimization of the renin angiotensin aldosterone system (RAAS) blockade were randomly assigned to receive 24 weeks' treatment with 2 μg/day paricalcitol or placebo. Primary endpoint was change in UPCR, and main secondary endpoints were change in urinary albumin-to-creatinine ratio (UACR) and 24-h proteinuria. Analysis was by intention to treat. One hundred and sixty-eight patients undergo randomization, and 83 were allocated to paricalcitol, and 85 to placebo. Compared with baseline, UPCR declined in the paricalcitol group (-39%, 95% CI -45 to -31) but not in the placebo group (21%, 95% CI 9 to 35), with a between group difference of -49% (95% CI -57 to -41; P < 0.001). UACR and 24-h proteinuria decreased only on paricalcitol therapy and significantly differed between groups at end-of-treatment (P < 0.001). Paricalcitol was well tolerated but incidence of mild hypercalcemia was higher than in placebo. In conclusion, addition of 2 μg/day paricalcitol lowers residual proteinuria in kidney transplant recipients. Long-term studies are needed to determine if the reduction in proteinuria improves transplant outcomes (ClinicalTrials.gov, number NCT01436747). |
| Databáze: | OpenAIRE |
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