Impact of Full Correction of Post-transplant Anemia on the Cardiovascular System and Quality of Life in Renal Transplant Recipients Receiving Erythropoietin Stimulating Agents: a Prospective Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 主要终点
- 1 year mortality
研究概览
简要总结
Background:
Post-transplant anemia (PTA) might be associated cardiovascular morbidity and even increased mortality. Objectives:
We aimed to assess the impact of full correction of chronic PTA on cardiovascular system and quality of life in renal transplant recipients with stable graft function using erythropoietin stimulating agents.
Patient and methods: We enrolled 247 kidney recipients with stable graft function to be assessed for anemia. Eligible patients were randomized to achieve target hemoglobin between 11 to 12 g/dl (group 1, n=183), or 13 to 15 g/dl (in group 2, n=64) using ESA. Monthly clinical and laboratory evaluation of kidney graft function was carried out. Moreover, quality of life (QOL) and echocardiography were assessed at the start and at 12 months.
详细描述
Two hundred and eighty anemic renal transplant recipients with stable graft function- who are followed up in Hamed Al-Essa organ transplant centre - will be assessed for the possible causes of their anemia. Anemia will be defined as Revised European Best Practice guidelines for anemia in renal tx, a Hb level of <11 g/dl should trigger treatment with ESA.
Drugs:
After patients' assessment for possible causes of anemia, each patient will be managed according to the specific cause of anemia i.e. iron, folic, and vitamin b12 deficiencies will be corrected. If anemia will be improved, we will consider such group of patients as corrected group, but if we failed to find specific cause of anemia we will consider them for ESA. Iron supplementation is permitted in order to maintain serum ferritin in the range 100-800 ng/ml or transferring saturation (TSAT) in the range 20-50%. Medications known to affect Hb concentration-e.g. angiotensin converting enzyme inhibitors (ACEI) & angiotensin receptor blockers (ARBS) - will be maintained at a stable dose if already prescribed at the start of the study.
Patients who fulfilled the following criteria will be included in the study:
Adult renal transplant patients (≥18 years). Informed consent. Stable maintenance subcutaneous darbepoetin alfa therapy with constant dose interval during the last 2 months.
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
- Single (Participant)
盲法说明
INVESTIGATOR
入排标准
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfilled the following criteria were included in the study:
- •Adult renal transplant patients (≥21years),
- •Informed consent,
- •Stable maintenance subcutaneous ESA therapy with constant dose interval during the last 2 months,
- •Haemoglobin (Hb) ≥10mg/dL (Hct 32%),
- •Transferrin saturation (TSAT) ≥20% (during the screening phase),
- •and serum ferritin ≥100 ng/mL
排除标准
- •We excluded patients with the following criteria:
- •Acute or chronic bleeding, or erythrocyte transfusion, within the preceding 8 weeks. change in Hb level ≥ 2 g/dL during screening phase,
- •Hemolytic anemia,
- •Recent infection or rejection,
- •Diastolic blood pressure >100mmHg or discontinuation of ESA due to hypertension in the 6 months prior to study,
- •Vitamin B12 or folic acid deficiency,
- •Uncontrolled or secondary hyperparathyroidism,
- •Acute or chronic systemic inflammatory disease and/or C-reactive protein (CRP) >30 mg/L,
- •Hemodialysis due to failure of a kidney transplant,
- •and malignancy
结局指标
主要结局
1 year mortality
时间窗: 12 months
number of deaths during 1st year of the study related to full correction of PTA
次要结局
未报告次要终点