Status:
UNKNOWN
Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients
Lead Sponsor:
Anemia Working Group Romania
Conditions:
Anaemia Response to the Treatment
Peripheral Iron Indices
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
The administration of ascorbic acid seemed to increase the iron available for erythropoiesis, thus improving the anemia response to the treatment. The investigators therefore aimed to evaluate the ef...
Detailed Description
Renal anemia is a complex condition in which chronic inflammation, among other factors, can change the iron distribution by locking it in deposits, and also, iron metabolism parameters. Thus, is hard ...
Eligibility Criteria
Inclusion
- Age above 18 years old
- At least 6 months on hemodialysis at the time of randomization;
- Kt/V≥1.2;
- average of the last three serum ferritin levels \> 500 ng/mL AND
- Average of the last three TSAT levels \> 20% and increasing
- ERI in the 4th quartile of the group
Exclusion
- Active bleeding or other cause of anemia
- Serum level of intact parathyroid hormone (iPTH)\>800 pg/mL
- Actual neoplasia
- HIV, Hepatitis B or C infections
- Significant inflammation (CRP\>12mg/L) or acute infection
- Venous central catheter
- Severe hepatic, cardiovascular, psychic disease or other severe comorbidities
- Moderate or severe malnutrition
- Blood transfusions in the 2 months prior to screening
- Pregnancy or breastfeeding
- Inclusion in another clinical trial in the past month
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02225886
Start Date
February 1 2020
End Date
December 1 2023
Last Update
February 24 2020
Active Locations (1)
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1
"Nefrolab" Dialysis Center
Slatina, Romania