Comparison Among Erythropoietin Stimulating Agents
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|ClinicalTrials.gov Identifier: NCT02049346|
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : September 13, 2017
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* Background: Despite extensive use, to the best of our knowledge, no trial has simultaneously compared the three currently used erythropoietin stimulating agents (ESAs) in a prospective manner, in treatment of anemia of end stage renal disease (ESRD) patients.
* Patients and Methods: All haemodialysis patients in Qatar who were treated with short acting Epoetin alfa or beta were screened. Eligible patients were randomized, either to continue on the previous regimen of Epoetin, or to receive Darbepoetin alfa or continuous erythropoietin receptor activator (C.E.R.A) for a total period of 40 weeks. All groups were assessed at the end of the study for safety and efficacy parameters.
|Condition or disease||Intervention/treatment||Phase|
|Anemia of End Stage Renal Disease||Drug: Epoetin alpha or beta (Epoetin group) Drug: Darbepoetin alfa Drug: Methoxy polyethylene glycol-epoetin beta||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||327 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: Epoetin alpha or beta (Epoetin group)
Patients in that arm were continued on the previous same dose and route of administration of Epoetin alpha/ beta (Epoetin group).
Drug: Epoetin alpha or beta (Epoetin group)
Erythropoetin doses in that were adjusted according to the approved prescribing information, without additional restrictions.
Doses of erythropoetin were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. erythropoetin doses were increased by 50% for Hb <10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.
The doses for all patients were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study.
Active Comparator: Darbepoetin alpha
subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol.
Drug: Darbepoetin alfa
Subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol. Doses of Darbepoetin alfa were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. Darbepoetin alfa doses and increased by 50% for Hb <10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.
The doses were adjusted so that haemoglobin concentrations were remain within a target range of 11-12 g/dL during the study.
If a dose of Epoetin alpha/ beta does not equate exactly to a unit dose of Darbepoetin alfa at switching, then the nearest available unit dose of Darbepoetin alfa was used.
Other Name: Aranesp
Experimental: Methoxy polyethylene glycol-epoetin beta
Patients in that arm received Intravenous Methoxy polyethylene glycol-epoetin beta monthly.
Drug: Methoxy polyethylene glycol-epoetin beta
Patients in that arm received Intravenous MIRCERA monthly. The initial dose was 120 mcg, 200 mcg or 360 mcg, for patients had previously received a weekly dose of Epoetin alpha/ beta of less than 8000 IU, between 8000 to16 000 IU or more than16000IU respectively. MIRCERA doses were adjusted according to the approved prescribing information, without additional restrictions.
Doses of MIRCERA were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. MIRCERA doses were increased by 50% for Hb <10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.
The doses of MIRCERA were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study.
Other Name: MIRCERA
- Comparison of efficacy among erythropoetin stimulating agents. [ Time Frame: Every week up to 36 weeks ]To evaluate efficacy of continuous erythropoietin receptor activator (C.E.R.A.) and Darbepoetin Alfa, to maintain Hemoglobin level - within the target recommended range - among ESRD patients, in direct comparison to currently available ESA (Epoetin alfa and beta). by measuring percentage of cases with mean Hemoglobin concentration between 11-12 gm/dl and measuring mean monthly hemoglobin concentrations.
- comparison between safety profile of different types of erythropoetin simulating agents. [ Time Frame: Up 36 weeks ]To compare the safety profile of the three groups (Epoetin, Darbepoetin alpha, C.E.R.A.) by the prevalence of associated morbidity and mortality.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Aged ≥18 years
- have stable chronic renal anemia (with hemoglobin range of 10-12 g/dL) and on regular haemodialysis 3 x week with urea reduction ratio greater or equal to 65% or KT/V ( K - dialyzer clearance of urea, t - dialysis time, V - volume of distribution of urea, approximately equal to patient's total body water) greater or equal to 1.2.
- Patients must have received haemodialysis three times weekly for ≥12 weeks before screening and during the 4-week screening/baseline period.
- Eligible patients must have stable hemoglobin concentrations (stable is defined as ≤25% change in weekly dose of ESA over 8 weeks).
- Recruited patients must have undergone continuous maintenance intravenous conventional Epoetin alpha or beta therapy for ≥8 weeks before screening and during the screening/baseline.
- Patients should have adequate iron status, defined as serum ferritin ≥100 μg/L and transferrin saturation ≥20%.
- New York Heart Association (NYHA) class III or IV congestive heart failure
Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure
- 105 mmHg or systolic BP≥ 160 mmHg during the screening period)
- Evidence of uncontrolled hyperparathyroidism (defined as parathyroid hormone level >1000 pg/ml with no response to conventional treatment of hyperparathyroidism according to Kidney Disease Outcomes Quality Initiative (KDOQI) guide line during the 12 months prior to baseline)
- Treatment for grand mal epilepsy
- Haematological, inflammatory or infectious conditions that might interfere with the erythropoietin response
- Received red blood cell transfusions within 12 weeks before screening or during the screening/baseline period.
- reactive protein >30 mg/L
- The likelihood of early withdrawal; or life expectancy of <12 months
- Poor compliance with dialysis treatment, evidenced by >2 missed treatment monthly over the previous 3 months10. Refuse to be involved in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049346
|Fahd Bin Jassem Dialysis Centre|
|Doha, Qatar, 30550|
|Principal Investigator:||Fadwa S. AL-Ali, MD||Hamad Medical Corporation|
|Responsible Party:||Hamad Medical Corporation|
|Other Study ID Numbers:||
|First Posted:||January 30, 2014 Key Record Dates|
|Last Update Posted:||September 13, 2017|
|Last Verified:||January 2014|
Erythropoetin Stimulating Agents
Kidney Failure, Chronic
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Renal Insufficiency, Chronic