Proactive High Dose Versus Low-dose Reactive Intravenous or Oral Iron in People on Peritoneal Dialysis (PALaDIN) - an Open-label, Feasibility Randomised Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Eligibility to consent rate (%)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oral
Ferrous Sulphate 200mg once daily (oral)
干预措施: Ferrous Sulfate (Drug)
Reactive Intravenous
IV Monofer up to every 3 months. Administered if ferritin <100 ug/L and TSAT <20%
干预措施: Monofer (iron isomaltoside 1000) (Drug)
Proactive Intravenous
IV Monofer up to every 3 months. Administered if ferritin <700 ug/L and TSAT <40%
干预措施: Monofer (iron isomaltoside 1000) (Drug)
结局指标
主要结局
Eligibility to consent rate (%)
时间窗: From enrollment to the end of treatment at 12 months
This refers to the proportion of participants who are eligible for the study and who provide informed consent to participate. Measuring Eligibility to Consent Eligibility-to-Consent Rate: (Number of eligible participants who consented / Total number of eligible participants) × 100% A low eligibility-to-consent ratio may suggest challenges in participant engagement, while a high ratio indicates good participant willingness to take part.
Recruitment rate (%)
时间窗: From enrollment to the end of treatment at 12 months
The recruitment rate refers to the speed at which participants are enrolled into a study over a given time period. Measuring Recruitment Rate Recruitment Rate: (Number of participants enrolled / Time period, e.g., per month) For multi-site studies, it can be adjusted per site: Recruitment Rate per Site: (Total participants enrolled / Number of sites × Time period) A high recruitment rate suggests effective recruitment strategies, while a low rate may highlight recruitment barriers.
Participant retention to 12 month follow-up (%)
时间窗: From enrollment to the end of treatment at 12 months
Participant retention refers to the proportion of participants who remain in the study and complete follow-up assessments over time. Measuring Retention Retention Rate at Follow-Up: (Number of participants completing follow-up assessments / Total participants enrolled) × 100% A high retention rate reflects good participant engagement, while a low rate may suggest challenges such as participant burden or study fatigue.
Treatment adherence (%)
时间窗: From enrollment to the end of treatment at 12 months
Treatment adherence refers to how well participants follow the prescribed treatment regimen, whether it is medication, lifestyle changes, or other interventions. Measuring Adherence Adherence Rate: (Number of prescribed doses/sessions completed / Total prescribed doses/sessions) × 100% A high adherence rate indicates good compliance, while a low rate may indicate barriers such as treatment side effects, participant preference, or complexity of the regimen.
Completion of clinical outcomes at follow-up and patterns of missing data for the study measures (%)
时间窗: From enrollment to the end of treatment at 12 months
This refers to the proportion of participants who complete the clinical outcomes measures at follow-up. Measuring Completion of Clinical Outcomes Completion Rate of Clinical Outcomes: (Number of participants with complete clinical outcome data / Total participants expected at follow-up) × 100% This measures how well the study is able to collect necessary data, with a high completion rate indicating effective data collection processes.
Completion of patient symptom questionnaires throughout the study (%)
时间窗: From enrollment to the end of treatment at 12 months
This refers to the proportion of scheduled symptom questionnaires that participants complete during the study. It is an important measure of participant engagement and the completeness of patient-reported outcome data. Measuring Completion of Patient Symptom Questionnaires Questionnaire Completion Rate: (Number of completed questionnaires / Total number of expected questionnaires) × 100% A high completion rate indicates good participant involvement and reliable data, while a low rate may suggest that the questionnaires are burdensome, inconvenient, or not seen as valuable by participants.
Treatment fidelty (%)
时间窗: From enrollment to the end of treatment at 12 months
Treatment fidelity refers to the degree to which the intervention is delivered as per the study protocol, ensuring consistency across all participants and study sites. Measuring Fidelity Fidelity Rate: (Number of intervention components delivered as intended / Total expected intervention components) × 100% A high fidelity rate suggests that the intervention is being delivered consistently as intended, while a low rate may indicate deviations in protocol delivery.
Treatment acceptability (%)
时间窗: From enrollment to the end of treatment at 12 months
Treatment acceptability refers to how acceptable participants or healthcare providers find the study intervention, including factors such as ease of use, side effects, and perceived effectiveness. Measuring Acceptability Acceptability Rate: (Number of participants rating treatment as acceptable / Total participants assessed) × 100% Acceptability is often measured through surveys or questionnaires, and a high rate indicates that participants find the treatment tolerable and beneficial. Low acceptability may highlight barriers such as side effects or perceived inefficacy.
次要结局
- Hospital Admissions(From enrollment to the end of treatment at 12 months)
- Drug Reactions(From enrollment to the end of treatment at 12 months)
- Quality of life (KDQoL-SF)(From enrollment to the end of treatment at 12 months)
- Adverse and serious adverse events(From enrollment to the end of treatment at 12 months)
- % Receiving Rescue Therapy(From enrollment to the end of treatment at 12 months)
- Quality-Adjusted Life Years(From enrollment to the end of treatment at 12 months)
- Symptom burden (IPOS-Renal, PROMIS Global Health Instrument)(From enrollment to the end of treatment at 12 months)
- % with Haemoglobin >110g/L(From enrollment to the end of treatment at 12 months)
- Ferritin >200ug/L(From enrollment to the end of treatment at 12 months)
- TSAT >20%(From enrollment to the end of treatment at 12 months)
- Change in Erythropoiesis-Stimulating Agent (ESA) Dose(From enrollment to the end of treatment at 12 months)
- Cumulative Iron Dose(From enrollment to the end of treatment at 12 months)
- Cost per Outcome(From enrollment to the end of treatment at 12 months)
- Mortality and Major Adverse Cardiovascular Events (MACE)(From enrollment to the end of treatment at 12 months)
- Infections and Peritoneal Dialysis Peritonitis(From enrollment to the end of treatment at 12 months)
- Physical Function (6-Minute Walk Test)(From enrollment to the end of treatment at 12 months)
- Cognitive Function (MoCA)(From enrollment to the end of treatment at 12 months)
- Residual Renal Function (Creatinine Clearance)(From enrollment to the end of treatment at 12 months)
- Restless Legs Syndrome (IRLSSG)(From enrollment to the end of treatment at 12 months)
- >10g/L Rise in Haemoglobin (Hb)(From enrollment to the end of treatment at 12 months)