Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

Официальное название

Proactive High Dose Versus Low-dose Reactive Intravenous or Oral Iron in People on Peritoneal Dialysis (PALaDIN) - an Open-label, Feasibility Randomised Study

Обзор

Chronic kidney disease affects a significant portion of the UK population, with approximately 3.5 million adults diagnosed. At its most severe stage, end-stage kidney disease, individuals require frequent dialysis treatment. One form of dialysis, known as peritoneal dialysis, involves introducing and removing fluid from the abdominal cavity to help filter out toxins from the body. The kidneys are involved in various hormonal processes, including those responsible for producing red blood cells, making anaemia a common consequence of kidney failure. When designing a clinical trial to evaluate the effectiveness of any treatment, it is essential to determine the number of suitable and willing participants, as well as those who can complete all required tests and measurements. Identifying the most appropriate measurement to assess the impact of intravenous iron (iron injected directly into veins) is crucial to ensure that any observed changes are meaningful to people with CKD and their carers. To address these considerations, the investigators will conduct a pilot feasibility trial. In this trial, individuals with kidney disease undergoing peritoneal dialysis will be randomly assigned to receive either high-dose or low-dose intravenous iron, or oral iron therapy. Over twelve months, the investigators will monitor their anaemia response, symptoms of kidney disease, quality of life, physical performance (such as the ability to walk for six minutes), and cognitive function. Additionally, the investigators will assess the impact of each intervention on the frequency of blood transfusions, whether those on oral iron require intravenous iron, and any changes in the dosage of erythropoietin-stimulating agents (drugs that increase blood production).

Вмешательства

• Препарат Monofer (iron isomaltoside 1000)
  Intravenous iron infusion, administered in this study up to every 3 months. Dosage determined by haemoglobin and weight.
• Препарат Ferrous Sulfate
  Oral iron tablet taken once daily for duration of study.

Первичные конечные точки

• Eligibility to consent rate (%) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Recruitment rate (%) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Participant retention to 12 month follow-up (%) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Completion of clinical outcomes at follow-up and patterns of missing data for the study measures (%) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Completion of patient symptom questionnaires throughout the study (%) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Treatment adherence (%) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Treatment fidelty (%) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Treatment acceptability (%) [Срок оценки: From enrollment to the end of treatment at 12 months]

Вторичные конечные точки (12)

• Adverse and serious adverse events [Срок оценки: From enrollment to the end of treatment at 12 months]
• Mortality and Major Adverse Cardiovascular Events (MACE) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Hospital Admissions [Срок оценки: From enrollment to the end of treatment at 12 months]
• Drug Reactions [Срок оценки: From enrollment to the end of treatment at 12 months]
• Infections and Peritoneal Dialysis Peritonitis [Срок оценки: From enrollment to the end of treatment at 12 months]
• Quality of life (KDQoL-SF) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Symptom burden (IPOS-Renal, PROMIS Global Health Instrument) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Physical Function (6-Minute Walk Test) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Cognitive Function (MoCA) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Residual Renal Function (Creatinine Clearance) [Срок оценки: From enrollment to the end of treatment at 12 months]
• Restless Legs Syndrome (IRLSSG) [Срок оценки: From enrollment to the end of treatment at 12 months]
• >10g/L Rise in Haemoglobin (Hb) [Срок оценки: From enrollment to the end of treatment at 12 months]

Критерии участия

Критерии включения

• Males and females aged ≥18 years.
• Able to give informed consent
• Serum ferritin <700ug/L
• Transferrin saturation level <40%
• No intravenous iron for last 4 weeks before randomisation (patients may be pre-identified and included after 4-week washout period)
• Received maintenance peritoneal dialysis therapy for at least 4 weeks
• Expected to remain on peritoneal dialysis therapy for duration of study

Критерии исключения

• Inadequate dialysis deemed by responsible clinician
• Probability of need for transfusion within 1 week of enrolment
• On or received a HIF-PHI in the past 4 weeks
• Anticipated major surgery that the responsible clinician feels will impact response to treatment
• Haemochromatosis / haemosiderosis or ALT >x3 normal
• Are deemed to be most suited to best-supportive or end-of-life care at time of screening
• Women of childbearing potential not using effective means of contraception
• Have been involved in another medicinal study (CTIMP) within past 4 weeks
• Known allergy or adverse reaction to oral or intravenous iron preparations
• CRP >50, TSATs >40%, SF >700 at time of recruitment
• Active infection, HIV, active Hep B or C
• Are unable or unwilling to consent to or complete the study procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Hull University Teaching Hospitals NHS Trust — Hull

Идентификаторы

NCT: NCT06884280 · R4171

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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