Spanish Registry of Erythropoietic Stimulating Agents Study (SPRESAS)
|ClinicalTrials.gov Identifier: NCT01739452|
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : April 9, 2015
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||722 participants|
|Observational Model:||Case Control|
|Official Title:||National Registry of Patients Diagnosed With Low-risk Myelodysplastic Syndromes According to the Criteria of the WHO / French-American-British Classification System (FAB) and IPSS and Treated With Erythropoietic Agents.|
|Study Start Date :||January 2013|
|Primary Completion Date :||May 2014|
|Study Completion Date :||September 2014|
Patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1), treated with erythropoiesis-stimulating agents.
A control group of patients who received only transfusional support.
- Collect and evaluate the Spanish experience of anemia treatment. [ Time Frame: 6 months ]Collect and evaluate retrospectively the Spanish experience of anemia treatment in patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1) evaluating the efficacy and safety of treatment with ESAs received for at least 24 weeks and the evolution of a control group of patients who received only transfusional support.
- Duration of response [ Time Frame: 6 months ]In responders at week 24 of treatment, determine the duration of response after 48 weeks of treatment.
- Overall survival. [ Time Frame: 6 months ]Evaluate overall survival in the two groups of patients, support transfusional versus ESA.
- Adverse events [ Time Frame: 6 months ]Security: To determine the frequency, type, intensity and severity of adverse events and their possible relationship with the various ESA and progression to acute myelogenous leukemia.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01739452
|Study Chair:||Maria Consuelo Cañizo, MD||Hospital Universitario de Salamanca|
|Study Chair:||María Díez, MD||Hospital Universitario de Salamanca|