JP2016535783A - 反応性が低下した患者のエリトロポエチン刺激剤の用量を減少させる方法 - Google Patents
反応性が低下した患者のエリトロポエチン刺激剤の用量を減少させる方法 Download PDFInfo
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Abstract
Description
赤血球造血刺激剤
ヘモグロビン
SFP組成物
透析及び溶液
患者集団
フェリチンレベルの増加
血液透析液を介した可溶性ピロリン酸第二鉄(SFP)のデリバリーによるESRD対象の生理的鉄維持:PRIME試験
目的
この試験は、血液透析液を介して投与される可溶性ピロリン酸第二鉄(SFP)の規則的な投与が、維持血液透析(HD)を受けている末期腎性疾患(ESRD)対象が鉄欠乏を発症するのを安全かつ効果的に予防するという仮説を検討するために設計された。SFPを含有する透析溶液を用いて透析した対象と標準透析液を用いて透析を受ける無作為化した対象(プラセボ)を比較した。
方法
計画:100
実際:108(無作為化:108;試験薬剤服用:104)。
評価基準:
統計的方法:
結果の要約
結論
実施例2
SFPの投与は、ESAへの反応性が低下している患者のESA必要性を減少させる。
Claims (25)
- エリトロポエチン刺激剤(ESA)への反応性が低下している透析患者を治療する方法であって、(a)患者に可溶性のピロリン酸第二鉄組成物(SFP)を投与すること、及び
(b)前記患者にESAへの反応性が低下しており、SFPを服用していない透析患者が必要とするESAの用量より少なくとも50%少ないESAの用量を投与することを含む前記方法。 - 前記SFPの用量が筋肉内、皮下、静脈内、皮内、経皮、経口腔、舌下、腹膜内からなる群から選択される非経口的経路を介して、または血液透析溶液もしくは腹膜透析溶液を介した透析的輸送により投与される、請求項1に記載の方法。
- 前記SFPの用量が経口で投与される、請求項1に記載の方法。
- 前記SFPの用量が、ヘパリンなどの他の薬剤または非経口的栄養混合物もしくは透析溶液と組み合わせて投与される、請求項1から3のいずれか一項に記載の方法。
- 前記SFPの用量が前記患者のヘモグロビンレベルを9g/dL以上に増加させる、または維持する、請求項1から4のいずれか一項に記載の方法。
- 前記SFPの用量が90μgFe/L透析液〜120μgFe/L透析液の範囲の用量の血液透析液を介して投与される、請求項1、2、4及び5のいずれか一項に記載の方法。
- 前記SFPが110μgFe/L透析液の用量の血液透析液を介して投与される、請求項6に記載の方法。
- 前記SFPの用量が1時間当たり0.1〜2mgの鉄の速度で、1日当たり2.4mg〜48mgの鉄の範囲の用量で、点滴または静脈内注射を介して投与される、請求項1、2、4及び5のいずれか一項に記載の方法。
- 前記SFPの用量が1時間当たり0.1〜2mgの鉄の速度で1日当たり2.4mg〜48mgの鉄の範囲の用量で循環に投与される、請求項1、2、4及び5のいずれか一項に記載の方法。
- SFP投与後、前記患者に投与される前記ESAの用量が、SFP投与前に投与される前記ESAの用量より少なくとも70%少ない、請求項1から9のいずれか一項に記載の方法。
- 前記SFPが、シトレート及びピロホスフェートでキレート化した鉄を含む、請求項1から10のいずれか一項に記載の方法。
- 前記SFPが7重量%〜11重量%の量の鉄、少なくとも14重量%の量のシトレート、及び少なくとも10重量%の量のピロホスフェートを含む、請求項1から11のいずれか一項に記載の方法。
- 前記SFPが透析液を介して投与され、SFP投与後、静脈内に投与される鉄の用量がSFP投与前の静脈内に投与される鉄の用量より少なくとも10%少ない、請求項1から12のいずれか一項に記載の方法。
- 前記患者が、慢性腎疾患、任意でステージIII、IVまたはVの慢性腎疾患を患っている、請求項1から13のいずれか一項に記載の方法。
- 前記患者がステージIVまたはVの慢性腎疾患を患っている、請求項1から14のいずれか一項に記載の方法。
- 前記患者が血液透析を受けている、請求項1から15のいずれか一項に記載の方法。
- 前記患者が炎症による貧血を患っている、請求項1から16のいずれか一項に記載の方法。
- 前記患者が感染、任意で慢性感染症を患っている、請求項1から17のいずれか一項に記載の方法。
- 前記患者が癌、心不全、自己免疫性疾患、鎌型赤血球症、地中海貧血、失血、輸血反応、糖尿病、ビタミンB12欠乏、膠原病性血管系疾患、血小板減少性紫斑、セリアック病、エンドクリン欠乏状態、甲状腺機能低下、アジソン病、クローン病、全身紅斑性狼瘡、リウマチ様関節炎、若年リウマチ様関節炎、潰瘍性大腸炎、免疫不全症s、好酸球性筋膜炎、低免疫グロブリン血症、胸腺腫/胸腺癌腫、移植片対宿主病、前白血病、非血液学的症候群、フェルティ症候群、溶血尿毒症症候群、骨髄異形成症候群、夜間発作性血色素尿、骨骨髄線維症、汎血球減少症、赤芽球ろう、シェーンライン−ヘノッホ紫斑病、マラリア、タンパク質飢餓、月経過多症、全身硬化症、肝硬変、代謝低下状態、うっ血性心不全、慢性感染症、HIV/AIDS、結核、骨髄炎、B型肝炎、C型肝炎、エプスタインバーウイルス、パルボウイルス、T細胞白血病ウイルス、腸内細菌異常増殖症候群、赤血球膜障害、遺伝性球状赤血球症、遺伝性楕円赤血球症、赤血球酵素異常症、脾機能亢進、免疫溶血または発作性夜間血色素尿を患っている、請求項1から18のいずれか一項に記載の方法。
- SFPの用量が血液透析中に前記血液透析液溶液内で投与される、請求項1から19のいずれか一項に記載の方法。
- SFPが腹膜透析中に前記腹膜透析溶液内で投与される、請求項1から20のいずれか一項に記載の方法。
- SFPが非経口的栄養で非経口的栄養混合物内で投与される、請求項1から21のいずれか一項に記載の方法。
- SFPが、i)血清鉄、トランスフェリン飽和度、網赤血球ヘモグロビン、血清フェリチン、網赤血球数、及び全血ヘモグロビンからなる群から選択される少なくともひとつの鉄状態のマーカーを増加させる、及びii)目標ヘモグロビンレベルに達する、または維持するのに必要なESAの用量、または、全血、赤血球濃厚液または代用血液の輸血の必要性を減少させる治療有効用量で投与される、請求項1から22のいずれか一項に記載の方法。
- 前記患者が非貧血性鉄欠乏を患っており、前記治療有効用量のSFPを投与すると、前記患者の疲労を減少させ、身体及び認知能力を増加させる、または運動耐性を改善する、請求項23に記載の方法。
- SFPが、鉄と関連がある下肢不安症候群の臨床症状を減少させる、または除去する治療有効用量で投与される、請求項1から24のいずれか一項に記載の方法。
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