Anemia of End Stage Renal DiseasePhase 4NCT02049346
Comparison Among Erythropoietin Stimulating Agents
A Phase 4 study testing Epoetin alpha or beta (Epoetin group), Darbepoetin alfa and Methoxy polyethylene glycol-epoetin beta in people with Anemia of End Stage Renal Disease, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of End Stage Renal Disease
- What is being tested?
- Epoetin alpha or beta (Epoetin group), Darbepoetin alfa and Methoxy polyethylene glycol-epoetin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteQatar
- Study dates
- Mar 2012to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar.
- 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.
Read the detailed description
- Objectives of the study
- Primary Objective 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).
- Secondary Objective To compare the safety profile of the three groups (Epoetin, Darbepoetin alpha, C.E.R.A.) by the prevalence of associated morbidity and mortality.
- Patients and Methods
- Study Subjects All haemodialysis patients of the main dialysis centers in Qatar (Doha, Alkhour and Alwakra) were screened.
- Study Design This is a prospective, randomized, comparative, open label study. The study has passed through three phases; the first phase was screening period for 4 weeks, the 2nd phase was titration period for 12 weeks and the third phase was evaluation period for 24 weeks. All patients have entered a 4-week screening/baseline period during which they continued to receive their previous Epoetin beta or alfa treatment. Eligible patients were then randomly assigned (1:1:1), either to continue on the previous same dose and route of administration of Epoetin alpha or beta (Epoetin group), or to receive Darbepoetin alfa (Aranesp ® Amgen) every week or 2weeks (Darbepoetin group) or methoxy polyethylene glycol-epoetin beta (Mircera ® Roche ,F. Hoffmann-La Roche, Basel, Switzerland) once monthly (C.E.R.A. group). In the second group Subjects who were receiving Epoetin alpha/ beta two or three times a week were switched to Darbepoetin alfa once a week, while those receiving Epoetin alpha or beta once a week were switched to Darbepoetin alfa once every 2 weeks. Two hundred IU Epoetin: 1 mcg Darbepoetin alfa ratio was used to determine the starting dose of Darbepoetin alfa. If a dose of Epoetin alpha or 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. Darbepoetin alfa doses were adjusted according to the approved prescribing information, without additional restrictions. In the third group Mircera® (F.Hoffmann-La Roche Ltd., Basel, Switzerland) is provided as pre-filled syringes. Intravenous monthly administration was carried out. The initial dose was 120 mcg, 200 mcg or 360 mcg, provided that patient had previously received a weekly dose of Epoetin alpha/ beta of less than 8000 IU, between 8000 to16 000 IU or more than16000IU respectively. Doses of C.E.R.A. were adjusted according to protocol and not more than once monthly. Doses of C.E.R.A. were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. C.E.R.A. dose was 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 would remain within a target range of 11-12 g/dL during the study. Iron supplementation was to be initiated or intensified according to centre practice in cases of iron deficiency (serum ferritin <100 μg/L, transferrin saturation <20%, or hypochromic red blood cells >10%) and discontinued in patients who had serum ferritin levels >800 μg/L or transferring saturation >50%. The study was conducted in accordance with the revised Declaration of Helsinki, and the study protocol was approved by our internal research committee. Written informed consent was obtained from all studied patients.
- Sample Size and Technique One hundred and ten patients were planned to be recruited in each arm according to number of eligible subjects after screening period. (Alpha= 0.05, B= 0.20 having 66% response rate by MIRCERA , 40.4% response rate by darbepoetin alpha So by comparing the sample size happened to be 107 individual for each group.[Statistical methods for rates and proportion by Joseph L. Fleiss (2nd. 1981, John Wiley \& Sons, NY), chapter 3]. The study has primarily evaluated the whole population of haemodialysis patients in Qatar. Laboratory assessment of the haemoglobin, haematocrit, white blood cell count, platelet count was measured at weekly intervals. Aspartate amino transferase, alanine aminotransferase, albumin, alkaline phosphatase, C- reactive protein, potassium, phosphorus, serum ferritin, serum iron, serum transferrin, total iron-binding capacity were measured at monthly intervals. Physical examinations including chest, heart, abdomen examination and evaluation of the volume status were performed at baseline, monthly and at the final visit. Fractional clearance of urea (Kt/V) or urea reduction ratio was used to assess adequacy of haemodialysis at baseline then monthly as unit protocol. Data were collected in data collection forms.
- Data Management and Analysis plan Collected data was fed in excel sheet and then converted to SPSS 14.0 statistical package for analysis. Descriptive statistics were performed for all the continuous and categorical variables appropriately. Parametric and non parametric statistical techniques were applied to see significance difference between the groups. P value 0.05 (two tailed) or less was considered as statistical significant level.
- Conditions
- Anemia of End Stage Renal Disease
- Being tested
- Epoetin alpha or beta (Epoetin group), Darbepoetin alfa, Methoxy polyethylene glycol-epoetin beta
- Keywords
- Anemia, Hemodialysis, Erythropoetin Stimulating Agents, Comparison
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin alpha or beta (Epoetin group)Drug
Also called Recormon, Eprex
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.
Darbepoetin alfaDrug
Also called Aranesp
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.
Methoxy polyethylene glycol-epoetin betaDrug
Also called MIRCERA
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.
| Study group | Role | What they receive |
|---|---|---|
| Epoetin alpha or beta (Epoetin group) | Active comparator | Patients in that arm were continued on the previous same dose and route of administration of Epoetin alpha/ beta (Epoetin group). Receives: Drug: Epoetin alpha or beta (Epoetin group) |
| Darbepoetin alpha | Active comparator | subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol. Receives: Drug: Darbepoetin alfa |
| Methoxy polyethylene glycol-epoetin beta | Experimental | Patients in that arm received Intravenous Methoxy polyethylene glycol-epoetin beta monthly. Receives: Drug: Methoxy polyethylene glycol-epoetin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of efficacy among erythropoetin stimulating agents.
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.
Measured: Every week up to 36 weeks
Secondary outcomes (1)
comparison between safety profile of different types of erythropoetin simulating agents.
To compare the safety profile of the three groups (Epoetin, Darbepoetin alpha, C.E.R.A.) by the prevalence of associated morbidity and mortality.
Measured: Up 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia of End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fadwa S. AL-Ali, MD, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049346
- Sponsor's protocol ID
- 11021/11
- Status last verified
- Jan 2014
- First submitted
- 22 Jan 2014
- Last updated
- 13 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar.
- ClinicalTrials.gov ID
- NCT02049346
- Acronym / sponsor ID
- 11021/11
- Conditions
- Anemia of End Stage Renal Disease
- Keywords
- Anemia, Hemodialysis, Erythropoetin Stimulating Agents, Comparison
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Detailed description
- Objectives of the study
- Primary Objective 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).
- Secondary Objective To compare the safety profile of the three groups (Epoetin, Darbepoetin alpha, C.E.R.A.) by the prevalence of associated morbidity and mortality.
- Patients and Methods
- Study Subjects All haemodialysis patients of the main dialysis centers in Qatar (Doha, Alkhour and Alwakra) were screened.
- Study Design This is a prospective, randomized, comparative, open label study. The study has passed through three phases; the first phase was screening period for 4 weeks, the 2nd phase was titration period for 12 weeks and the third phase was evaluation period for 24 weeks. All patients have entered a 4-week screening/baseline period during which they continued to receive their previous Epoetin beta or alfa treatment. Eligible patients were then randomly assigned (1:1:1), either to continue on the previous same dose and route of administration of Epoetin alpha or beta (Epoetin group), or to receive Darbepoetin alfa (Aranesp ® Amgen) every week or 2weeks (Darbepoetin group) or methoxy polyethylene glycol-epoetin beta (Mircera ® Roche ,F. Hoffmann-La Roche, Basel, Switzerland) once monthly (C.E.R.A. group). In the second group Subjects who were receiving Epoetin alpha/ beta two or three times a week were switched to Darbepoetin alfa once a week, while those receiving Epoetin alpha or beta once a week were switched to Darbepoetin alfa once every 2 weeks. Two hundred IU Epoetin: 1 mcg Darbepoetin alfa ratio was used to determine the starting dose of Darbepoetin alfa. If a dose of Epoetin alpha or 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. Darbepoetin alfa doses were adjusted according to the approved prescribing information, without additional restrictions. In the third group Mircera® (F.Hoffmann-La Roche Ltd., Basel, Switzerland) is provided as pre-filled syringes. Intravenous monthly administration was carried out. The initial dose was 120 mcg, 200 mcg or 360 mcg, provided that patient had previously received a weekly dose of Epoetin alpha/ beta of less than 8000 IU, between 8000 to16 000 IU or more than16000IU respectively. Doses of C.E.R.A. were adjusted according to protocol and not more than once monthly. Doses of C.E.R.A. were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. C.E.R.A. dose was 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 would remain within a target range of 11-12 g/dL during the study. Iron supplementation was to be initiated or intensified according to centre practice in cases of iron deficiency (serum ferritin <100 μg/L, transferrin saturation <20%, or hypochromic red blood cells >10%) and discontinued in patients who had serum ferritin levels >800 μg/L or transferring saturation >50%. The study was conducted in accordance with the revised Declaration of Helsinki, and the study protocol was approved by our internal research committee. Written informed consent was obtained from all studied patients.
- Sample Size and Technique One hundred and ten patients were planned to be recruited in each arm according to number of eligible subjects after screening period. (Alpha= 0.05, B= 0.20 having 66% response rate by MIRCERA , 40.4% response rate by darbepoetin alpha So by comparing the sample size happened to be 107 individual for each group.[Statistical methods for rates and proportion by Joseph L. Fleiss (2nd. 1981, John Wiley \& Sons, NY), chapter 3]. The study has primarily evaluated the whole population of haemodialysis patients in Qatar. Laboratory assessment of the haemoglobin, haematocrit, white blood cell count, platelet count was measured at weekly intervals. Aspartate amino transferase, alanine aminotransferase, albumin, alkaline phosphatase, C- reactive protein, potassium, phosphorus, serum ferritin, serum iron, serum transferrin, total iron-binding capacity were measured at monthly intervals. Physical examinations including chest, heart, abdomen examination and evaluation of the volume status were performed at baseline, monthly and at the final visit. Fractional clearance of urea (Kt/V) or urea reduction ratio was used to assess adequacy of haemodialysis at baseline then monthly as unit protocol. Data were collected in data collection forms.
- Data Management and Analysis plan Collected data was fed in excel sheet and then converted to SPSS 14.0 statistical package for analysis. Descriptive statistics were performed for all the continuous and categorical variables appropriately. Parametric and non parametric statistical techniques were applied to see significance difference between the groups. P value 0.05 (two tailed) or less was considered as statistical significant level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epoetin alpha or beta (Epoetin group) | Active comparator | Drug: 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). |
| Darbepoetin alpha | Active comparator | Drug: Darbepoetin alfasubjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol. |
| Methoxy polyethylene glycol-epoetin beta | Experimental | Drug: Methoxy polyethylene glycol-epoetin betaPatients in that arm received Intravenous Methoxy polyethylene glycol-epoetin beta monthly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- New York Heart Association (NYHA) class III or IV congestive heart failure
- Uncontrolled hypertension (defined as pre-dialysis diastolic blood pressure
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epoetin alpha or beta (Epoetin group)Also: Recormon, EprexErythropoetin 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. | Drug | Epoetin alpha or beta (Epoetin group) |
| Darbepoetin alfaAlso: AranespSubjects 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. | Drug | Darbepoetin alpha |
| Methoxy polyethylene glycol-epoetin betaAlso: MIRCERAPatients 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. | Drug | Methoxy polyethylene glycol-epoetin beta |
Primary outcome
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.
1 secondary outcome
comparison between safety profile of different types of erythropoetin simulating agents.
Time frame: Up 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Related trials for Anemia of End Stage Renal Disease
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Active, not recruitingPhase 3
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Chronic Kidney Disease, Renal Anemia
Not yet recruitingPhase 2
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
Anemia
Recruiting
Studies on Adsorption International Learning Initiative Global
CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic
Not yet recruitingPhase 4
Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia
Anemia, Kidney Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fadwa S. AL-Ali, MD principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epoetin alpha or beta (Epoetin group), Darbepoetin alfa and Methoxy polyethylene glycol-epoetin beta in people with Anemia of End Stage Renal Disease, run by Hamad Medical Corporation at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of efficacy among erythropoetin stimulating agents. (time frame: Every week up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02049346, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.