IVIG vs SCIG in CIDP
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Intravenous immune globulin G, Subcutaneous immune globulin G.
- Кому может быть актуально
- Состояния в реестре: CIDP, Immunoglobulin Deficiency, Chronic Inflammatory Demyelinating Polyneuropathy. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Influence of Body Composition on Immunoglobulin Disposition After Intravenous and Subcutaneous Administration
Обзор
Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. The current study will evaluate the influence of body composition on intravenous and subcutaneous administration of immunoglobulin G in patients.
Подробное описание
Current dosing practices for immunoglobulin G (IgG) may be inadequate in extreme body weight. Total (TBW), ideal (IBW), and adjusted (AdjBW) body weight-based dosing strategies are suggested, but these recommendations are based on expert opinion rather than high quality evidence. The adoption of a specific strategy is highly variable depending on the clinician and/or institutional setting. Recently, payors have also adopted strategies to reduce IgG therapy costs of by capping doses. These recommendations are often based on the presumption that IgG distribution is limited to the vascular space. While this assertion is logical, it does not account for changes adipose tissue may confer on target sites, nor does it account for the potential for adipose tissue to function serve as a metabolic sink or a source of inflammatory mediators. The later would be especially important in patients receiving SCIG. Several observational studies have evaluated IgG dosing in obese patients and have been the source of support for dosing strategies. Many of these studies were not representative of specific populations, contained a wide variety of patients with different IgG indications, and had inadequate serum sampling. More recently, the phase III randomized controlled PATH trial did not find a correlation with serum IgG concentrations and clinical endpoints. However, it is important to note that the study was not designed to evaluate pharmacokinetic and pharmacodynamic endpoints. There is also considerable interpatient variation in response; therefore, identification of patient characteristics that predict response or IgG change from baseline will be a useful tool to improve patient responses. Our study will evaluate the influence of body composition and other patient characteristics may have on IgG exposure when given intravenously or subcutaneously.
Вмешательства
- Препарат Intravenous immune globulin G
Intravenous immune globulin G dosed based on the subjects's current dose received for the treatment of CIDP. - Препарат Subcutaneous immune globulin G
Subcutaneous immune globulin G converted from the subject's current IVIG dose 1:1.
Первичные конечные точки
- Assessment of drug half-life [Срок оценки: Through study completion, an average of 4 weeks]
- Assessment of immune globulin G serum concentration after intravenous immune globulin G administration [Срок оценки: Just before drug administration, immediately after drug administration, approximately days 7 and 14 post drug administration]
- Assessment of immune globulin G serum concentration after subcutaneous immune globulin G administration [Срок оценки: Just before drug administration, immediately after drug administration, approximately days 2, 4 and 7 post drug administration]
Вторичные конечные точки (4)
- Assessment of grip strength [Срок оценки: Baseline and just before administration of next immune globulin dose.]
- Assessment of muscle function [Срок оценки: Baseline and just before administration of next immune globulin dose.]
- Assessment of patient disability [Срок оценки: Baseline and just before administration of next immune globulin dose.]
- Assessment of fatigue [Срок оценки: Baseline and just before administration of next immune globulin dose.]
Критерии участия
Критерии включения
- Patients aged >18 years with a current diagnosis of CIDP (based on European Federation of Neurological sciences / Peripheral Nerve Society CIDP diagnostic criteria).
- 1:1 conversion of IVIG to SCIG (weekly dose conversion) must fall within 0.2-to-0.4 mg/kg dose for SCIG.
Критерии исключения
- Patients receiving IVIG for indications other than CIDP will be excluded.
- Patients with liver impairment (elevations in liver enzymes of greater than 3 times the upper limit of normal) or reduced renal function (CrCl < 50 mL/min) will be excluded
- Active malignancies
- Diabetes
- Myasthenia gravis
- Immunodeficiency
- Autoimmune disease
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- Rutgers, The State University of New Jersey Clinical Research Center — New Brunswick
Идентификаторы
NCT: NCT05584631 · Pro2019001038