• Je něco špatně v tomto záznamu ?

Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy

J. Barratt, R. Lafayette, J. Kristensen, A. Stone, D. Cattran, J. Floege, V. Tesar, H. Trimarchi, H. Zhang, N. Eren, A. Paliege, BH. Rovin, NefIgArd Trial Investigators

. 2023 ; 103 (2) : 391-402. [pub] 20221019

Jazyk angličtina Země Spojené státy americké

Typ dokumentu randomizované kontrolované studie, multicentrická studie, časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc23004424

The therapeutic potential of a novel, targeted-release formulation of oral budesonide (Nefecon) for the treatment of IgA nephropathy (IgAN) was first demonstrated by the phase 2b NEFIGAN trial. To verify these findings, the phase 3 NefigArd trial tested the efficacy and safety of nine months of treatment with Nefecon (16 mg/d) versus placebo in adult patients with primary IgAN at risk of progressing to kidney failure (ClinicalTrials.gov: NCT03643965). NefIgArd was a multicenter, randomized, double-blind, placebo-controlled two-part trial. In Part A, 199 patients with IgAN were treated with Nefecon or placebo for nine months and observed for an additional three months. The primary endpoint for Part A was 24-hour urine protein-to-creatinine ratio (UPCR) after nine months. Secondary efficacy outcomes evaluated included estimated glomerular filtration rate (eGFR) at nine and 12 months and the UPCR at 12 months. At nine months, UPCR was 27% lower in the Nefecon group compared with placebo, along with a benefit in eGFR preservation corresponding to a 3.87 ml/min/1.73 m2 difference versus placebo (both significant). Nefecon was well-tolerated, and treatment-emergent adverse events were mostly mild to moderate in severity and reversible. Part B is ongoing and will be reported on later. Thus, NefIgArd is the first phase 3 IgA nephropathy trial to show clinically important improvements in UPCR and eGFR and confirms the findings from the phase 2b NEFIGAN study.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc23004424
003      
CZ-PrNML
005      
20230425141356.0
007      
ta
008      
230418s2023 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.kint.2022.09.017 $2 doi
035    __
$a (PubMed)36270561
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Barratt, Jonathan $u College of Medicine Biological Sciences and Psychology, University of Leicester, Leicester, UK
245    10
$a Results from part A of the multi-center, double-blind, randomized, placebo-controlled NefIgArd trial, which evaluated targeted-release formulation of budesonide for the treatment of primary immunoglobulin A nephropathy / $c J. Barratt, R. Lafayette, J. Kristensen, A. Stone, D. Cattran, J. Floege, V. Tesar, H. Trimarchi, H. Zhang, N. Eren, A. Paliege, BH. Rovin, NefIgArd Trial Investigators
520    9_
$a The therapeutic potential of a novel, targeted-release formulation of oral budesonide (Nefecon) for the treatment of IgA nephropathy (IgAN) was first demonstrated by the phase 2b NEFIGAN trial. To verify these findings, the phase 3 NefigArd trial tested the efficacy and safety of nine months of treatment with Nefecon (16 mg/d) versus placebo in adult patients with primary IgAN at risk of progressing to kidney failure (ClinicalTrials.gov: NCT03643965). NefIgArd was a multicenter, randomized, double-blind, placebo-controlled two-part trial. In Part A, 199 patients with IgAN were treated with Nefecon or placebo for nine months and observed for an additional three months. The primary endpoint for Part A was 24-hour urine protein-to-creatinine ratio (UPCR) after nine months. Secondary efficacy outcomes evaluated included estimated glomerular filtration rate (eGFR) at nine and 12 months and the UPCR at 12 months. At nine months, UPCR was 27% lower in the Nefecon group compared with placebo, along with a benefit in eGFR preservation corresponding to a 3.87 ml/min/1.73 m2 difference versus placebo (both significant). Nefecon was well-tolerated, and treatment-emergent adverse events were mostly mild to moderate in severity and reversible. Part B is ongoing and will be reported on later. Thus, NefIgArd is the first phase 3 IgA nephropathy trial to show clinically important improvements in UPCR and eGFR and confirms the findings from the phase 2b NEFIGAN study.
650    _2
$a dospělí $7 D000328
650    _2
$a lidé $7 D006801
650    12
$a budesonid $x aplikace a dávkování $7 D019819
650    _2
$a dvojitá slepá metoda $7 D004311
650    _2
$a hodnoty glomerulární filtrace $7 D005919
650    12
$a IgA nefropatie $x farmakoterapie $7 D005922
650    _2
$a vyšetření funkce ledvin $7 D007677
650    _2
$a výsledek terapie $7 D016896
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a multicentrická studie $7 D016448
655    _2
$a časopisecké články $7 D016428
700    1_
$a Lafayette, Richard $u Division of Nephrology, Department of Medicine, Stanford University, Stanford, California, USA
700    1_
$a Kristensen, Jens $u Calliditas Therapeutics AB, Stockholm, Sweden
700    1_
$a Stone, Andrew $u Stone Biostatistics Ltd., Crewe, UK
700    1_
$a Cattran, Daniel $u Division of Nephrology, Toronto General Hospital Research Institute, University of Toronto, Toronto, Ontario, Canada
700    1_
$a Floege, Jürgen $u Department of Nephrology and Clinical Immunology, Rheinisch Westfälische Technische Hochschule Aachen University Hospital, Aachen, Germany
700    1_
$a Tesar, Vladimir $u Department of Nephrology, 1st School of Medicine and General University Hospital, Charles University, Prague, Czech Republic
700    1_
$a Trimarchi, Hernán $u Nephrology Service, Hospital Británico de Buenos Aires, Buenos Aires, Argentina
700    1_
$a Zhang, Hong $u Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, China
700    1_
$a Eren, Necmi $u Department of Nephrology, Kocaeli University, Kocaeli, Turkey
700    1_
$a Paliege, Alexander $u Division of Nephrology, Department of Internal Medicine III, University Hospital Carl Gustav Carus at the Technische Universität Dresden, Dresden, Germany
700    1_
$a Rovin, Brad H $u Division of Nephrology, the Ohio State University Wexner Medical Center, Columbus, Ohio, USA. Electronic address: Brad.Rovin@osumc.edu
710    2_
$a NefIgArd Trial Investigators
773    0_
$w MED00010141 $t Kidney international $x 1523-1755 $g Roč. 103, č. 2 (2023), s. 391-402
856    41
$u https://pubmed.ncbi.nlm.nih.gov/36270561 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20230418 $b ABA008
991    __
$a 20230425141352 $b ABA008
999    __
$a ok $b bmc $g 1924856 $s 1190633
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2023 $b 103 $c 2 $d 391-402 $e 20221019 $i 1523-1755 $m Kidney international $n Kidney Int $x MED00010141
LZP    __
$a Pubmed-20230418

Najít záznam

Citační ukazatele

Možnosti archivace