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Safety and Efficacy Study for AKB-6548 in Participants With Chronic Kidney Disease and Anemia

2022年6月7日 更新者：Akebia Therapeutics

Phase 2a Open-Label Pilot Study to Assess the Pharmacodynamic Response, Pharmacokinetics, Safety, and Tolerability of 28-Day Repeat Oral Doses of AKB-6548 in Subjects With Anemia Secondary to Chronic Kidney Disease (CKD), Stages 3 and/or 4

The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

10

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Georgia
      • Augusta、Georgia、アメリカ
    • Texas
      • San Antonio、Texas、アメリカ

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～79年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Key Inclusion Criteria:

  • 18 to 79 years of age, inclusive
  • Chronic Kidney Disease Stage 3 or Stage 4
  • Hemoglobin (Hgb) < 10.5 g/dl
  • TSAT > 20% and CBC indicating normocytic red blood cell morphology

Key Exclusion Criteria:

  • BMI > 40
  • Red blood cell transfusion within 12 weeks.
  • Androgen therapy within the previous 21 days prior to study dosing
  • Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 10 weeks prior to the Screening visit
  • Participants meeting the criteria of ESA resistance within the previous 4 months
  • Individual doses of intravenous iron of 250 mg or larger within the past 21 days
  • AST or ALT >1.8x ULN.
  • Alkaline phosphatase >2x ULN.
  • Total bilirubin >1.5x ULN.
  • Uncontrolled hypertension
  • New York Heart Association Class III or IV congestive heart failure
  • Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：AKB-6548
薬：AKB-6548
Different dose levels

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mean Change From Baseline in Hemoglobin (Hgb) on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates that hemoglobin concentration increased.
Baseline; Day 29

二次結果の測定

結果測定
メジャーの説明
時間枠
Mean Change From Baseline in Hematocrit on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess hematocrit. A positive change from baseline indicates hematocrit concentration increased.
Baseline; Day 29
Mean Change From Baseline in Total Red Blood Cell (RBC) Count on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates RBC count increased.
Baseline; Day 29
Mean Change From Baseline in Absolute Reticulocyte Count on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline). A positive change from baseline indicates absolute reticulocyte count increased.
Baseline; Day 29
Mean Change From Baseline in Reticulocyte Hemoglobin (Hgb) Content on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess reticulocyte Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline). A positive change from baseline indicates reticulocyte Hgb content increased.
Baseline; Day 29
Number of Participants With Absolute Change From Baseline in Hemoglobin (Hgb) at Day 29
時間枠：Day 29
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).
Day 29
Number of Participants With the Percentage Change From Baseline in Hemoglobin (Hgb) at Day 29
時間枠：Day 29
Blood samples were collected to assess Hgb. Baseline Hgb was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).
Day 29
Number of Participants With Percentage Change From Baseline in Hematocrit at Day 29
時間枠：Day 29
Blood samples were collected to assess hematocrit.
Day 29
Number of Participants With Percentage Change From Baseline in Red Blood Cell (RBC) Count at Day 29
時間枠：Day 29
Blood samples were collected to assess RBC count. Baseline RBC count was defined as the average of the 2 samples obtained prior to dosing (Pre-Baseline and Baseline).
Day 29
Number of Participants With Change From Baseline in Absolute Reticulocyte Count at Day 29
時間枠：Day 29
Blood samples were collected to assess reticulocyte count. Baseline absolute reticulocyte count was defined as the average of the 3 reticulocyte counts obtained prior to dosing (Screening, Pre- Baseline, and Baseline).
Day 29
Change From Baseline in Ferritin on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess ferritin. A positive change from baseline indicates ferritin content increased.
Baseline; Day 29
Change From Baseline in Iron on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess iron. A positive change from baseline indicates iron content increased.
Baseline; Day 29
Change From Baseline in Total Iron Binding Capacity on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess total iron binding capacity. A positive change from baseline indicates total iron binding capacity increased.
Baseline; Day 29
Change From Baseline in Transferrin Saturation on Day 29
時間枠：Baseline; Day 29
Blood samples were collected to assess transferrin saturation. The transferrin saturation is the ratio of the serum iron concentration and the total iron-binding capacity, expressed as a percentage. A positive change from baseline indicates transferrin saturation increased.
Baseline; Day 29
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
時間枠：Up to 2 weeks post 28 days of treatment
An Adverse Event (AE) was defined as any untoward medical occurrence, signs, symptoms, disease, or laboratory or physiological observations occurring in a participant administered with drug, regardless of a causal relationship with that treatment or usage. This also included all suspected adverse medication reactions, reactions from medication overdose, abuse, withdrawal, sensitivity, toxicity, unrelated illnesses, including worsening a pre-existing condition, injury, or accidents. Serious Adverse Events (SAEs) was defined as any life-threatening condition; hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or death.
Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
時間枠：Up to 2 weeks post 28 days of treatment
Parameters assessed for laboratory values included hematology, chemistry, urinalysis, and coagulation. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
時間枠：Up to 2 weeks post 28 days of treatment
Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing laboratory results for clinically significant changes.
Up to 2 weeks post 28 days of treatment
Number of Participants With Clinically Abnormal 12-Lead Electrocardiogram (ECG) Findings
時間枠：Up to 2 weeks post 28 days of treatment
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The investigator was responsible for reviewing laboratory results for clinical significance.
Up to 2 weeks post 28 days of treatment
Mean Change From Baseline in PR Interval, QT Interval, QRS Interval, and QT Corrected (QTc) Interval
時間枠：Up to 2 weeks post 28 days of treatment
A standard 12-lead ECG was performed following dosing in a supine position for approximately 10 minutes. ECGs were taken prior to blood draws when possible. The parameters evaluated from the participant ECG trace included PR interval, QT interval, QRS interval, and QTc (corrected).
Up to 2 weeks post 28 days of treatment
Mean Trough Concentrations of Vadadustat at Day 8, 15, 22 and 29
時間枠：Pre-dose at Day 8, 15, 22 and 29
Serum samples were collected from the participants at the defined time points. Trough concentration was defined as the concentration of drug in the blood immediately before the next dose is administered. Trough concentration was calculated using the validated liquid chromatography-mass spectrometry (LC-MS) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) method
Pre-dose at Day 8, 15, 22 and 29

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Akebia Therapeutics

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2010年10月21日

一次修了 (実際)

2011年4月13日

研究の完了 (実際)

2011年5月1日

試験登録日

最初に提出

2010年11月5日

QC基準を満たした最初の提出物

2010年11月5日

最初の投稿 (見積もり)

2010年11月8日

学習記録の更新

投稿された最後の更新 (実際)

2022年7月1日

QC基準を満たした最後の更新が送信されました

2022年6月7日

最終確認日

2022年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AKB-6548-CI-0004

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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