Anemia Clinical Trial
Official title:
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.
Verified date | February 2019 |
Source | Hamid Al-Essa Organ Transplant Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 280 |
Est. completion date | December 20, 2018 |
Est. primary completion date | December 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hamid Al-Essa Organ Transplant Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1 year mortality | number of deaths during 1st year of the study related to full correction of PTA | 12 months |
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