AnemiaPhase 3NCT00446576
The Effect of Epoetin Alfa on Cardiac Function and Quality of Life in Patients With Early Renal ((Kidney) Disease
A Phase 3 study testing Epoetin Alfa in people with Anemia, run by Janssen-Cilag B.V..
Trial summary
The purpose of this study is to assess whether maintaining hemoglobin (Hb) levels at normal or sub-normal levels with Epoetin Alfa can influence the health status, left ventricular mass and quality of life of early renal insufficiency subjects without additional safety concerns. Read more about this study
- Who is it for?
- Ages 18 to 73 years
- Conditions the study is for
- Anemia
- What is being tested?
- Epoetin Alfa
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Nov 1999to Apr 2003
- Phase
- Phase 3
- 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 to 73 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with early renal insufficiency who are not on haemodialysis
- A baseline Hb level of >7.5 mmol/l (120 g/l) but expected to decrease during the coming months. Allowed exceptions: Hb < 7,5 mmol/l (120 g/l) for a maximum of 6 months. In medical history an Hb < 7,0 mmol/l (113 g/l) is only allowed for a maximum period of 3 months and in relation to an accidental drop in Hb (f.e. caused by surgery, gastric bleeding etc.)
- Age: 18 - 73 years, given that patients >70 years are in good general condition and are expected to complete the 30 months study period
- Creatinine clearance < 40 ml/min/1.73 m2 (Cockcroft formula) or creatinin clearance < 50 ml/min/1.73 m2), given that the clearance and Hb show a downward tendency as demonstrated in the patient files and medical history
Who cannot join
- Presence of clinically significant disease/dysfunction of hepatic, pulmonary, hematological (e.g. sickle cell anaemia, thalassemia, major myelodysplastic syndromes, hemolytic anaemia), neurological, musculo-skeletal, endocrine, gastrointestinal or genitourinary system unrelated to underlying chronic renal failure which in the opinion of the investigator would disqualify the patient from this study
- Cystic kidney disease
- Clinical or laboratory evidence of untreated iron, folate or Vitamin B12 deficiency
- Presence of concomitant malignancy (other than basal cell carcinoma of the skin)
- Uncontrolled hypertension (i.e. diastolic blood pressure of > 100 mm Hg)
- History of seizures
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- Administration of medication known to suppress erythropoiesis (e.g. cytotoxic agents, immuno-suppressive) within one month prior to enrolment. Low dose steroid therapy will be permitted
- Pregnancy or lactation
- Known hypersensitivity to Epoetin alfa or one of its components.
About this study
Official title: A Study in Early Renal Insufficiency Patients to Assess the Effect of Maintaining Three Different Hemoglobin Levels With the Use of Erythropoetin Alpha on Left Ventricular Hypertrophy and Dilation and Quality if Life; The "Cardiac Results of Early Treatment of Anaemia (CRETA)" Study
The purpose of this study is to assess whether maintaining hemoglobin (Hb) levels at normal or sub-normal levels with Epoetin Alfa can influence the health status, left ventricular mass and quality of life of early renal insufficiency subjects without additional safety concerns.
Read the detailed description
The use of Epoetin alfa in the treatment of anaemia in chronic renal failure (CRF) patients is well accepted. The severity of anaemia in CRF patients increases with the degree of renal dysfunction. Thus, the most severe degree of anaemia is generally found in patients with end stage renal disease who must be maintained on dialysis. Nevertheless, a significant number of early renal insufficiency patients are also seen to be anaemic.
Most patients in Europe with end stage renal disease are maintained at an Hb level between 6 and 8 mmol/l. According to a survey during the second European Epoetin symposium (Creta, 1998) only 20% is maintained at Hb = 8 mmol/l, but most are maintained at values lower than 8 mmol/l. Even about 40% was maintained at Hb = 6 mmol/l.
A number of studies have found a relationship between left ventricular hypertrophy and haemoglobin in dialysis and pre-dialysis patients. Also a relation between LVH and morbidity and mortality has been found. For this reason it should be a suggestion to treat anaemia towards a higher level.
To treat Hb to a higher level a choice can be made to correct Hb when it has dropped to a very low level after renal disease has reached an advanced stage or alternatively to prevent anaemia in an early stage of renal disease. In an analysis of the normal hematocrit trial, Macdougall and Ritz suggest the latter. This is the main purpose of this trial.
Treatment with Epoetin alfa also makes patients feel better physically when their exercise capacity improves. During treatment with Epoetin alfa, several secondary effects may simultaneously influence the maximal exercise capacity after correction of the anaemia. The improved well-being may result in an increase in physical activity and exercise capacity can be further improved by such conditioning. The improved oxygen transport after correction of anaemia reverses the circulatory adaptation to hypoxia and most studies have shown a decrease in cardiac output at rest, and an increase in peripheral resistance. However, approximately one-third of chronic renal failure patients treated with Epoetin alfa have episodes of hypertension, and may require increased doses of anti-hypertensive medication.
This prospective study will assess whether maintaining Hb levels at normal or sub-normal levels can influence the health status, left ventricular mass and quality of life (QoL) of early renal insufficiency subjects without additional safety concerns. The patients will receive Epoetin Alfa as subcutaneous or intravenous injections in variable dosages for a maximum of 42 months
- Conditions
- Anemia
- Being tested
- Epoetin Alfa
- Keywords
- Anemia, early renal insufficiency
- Medical subject headings
- Anemia, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin AlfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in left ventricular mass index
Secondary outcomes (1)
Incidence of Left Ventricular hypertrophy QoL assessment (FACIT-Fatigue Scale and KDQOL-SFÒ) The change in pulse pressure during the study period. Morbidity and mortality during the study-period Deterioration of renal function Days in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startNov 1999
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag B.V. Clinical Trial, Study director, Janssen-Cilag B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446576
- Sponsor's protocol ID
- CR005599
- Status last verified
- Jan 2011
- First submitted
- 12 Mar 2007
- Last updated
- 1 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Early Renal Insufficiency Patients to Assess the Effect of Maintaining Three Different Hemoglobin Levels With the Use of Erythropoetin Alpha on Left Ventricular Hypertrophy and Dilation and Quality if Life; The "Cardiac Results of Early Treatment of Anaemia (CRETA)" Study
- ClinicalTrials.gov ID
- NCT00446576
- Acronym / sponsor ID
- CR005599
- Conditions
- Anemia
- Keywords
- Anemia, early renal insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Janssen-Cilag B.V.Industry (pharma, biotech, devices)
- Study start
- Nov 1999
- Study completion
- Apr 2003 (actual)
- First posted
- 13 Mar 2007 (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.
The purpose of this study is to assess whether maintaining hemoglobin (Hb) levels at normal or sub-normal levels with Epoetin Alfa can influence the health status, left ventricular mass and quality of life of early renal insufficiency subjects without additional safety concerns.
Detailed description
The use of Epoetin alfa in the treatment of anaemia in chronic renal failure (CRF) patients is well accepted. The severity of anaemia in CRF patients increases with the degree of renal dysfunction. Thus, the most severe degree of anaemia is generally found in patients with end stage renal disease who must be maintained on dialysis. Nevertheless, a significant number of early renal insufficiency patients are also seen to be anaemic.
Most patients in Europe with end stage renal disease are maintained at an Hb level between 6 and 8 mmol/l. According to a survey during the second European Epoetin symposium (Creta, 1998) only 20% is maintained at Hb = 8 mmol/l, but most are maintained at values lower than 8 mmol/l. Even about 40% was maintained at Hb = 6 mmol/l.
A number of studies have found a relationship between left ventricular hypertrophy and haemoglobin in dialysis and pre-dialysis patients. Also a relation between LVH and morbidity and mortality has been found. For this reason it should be a suggestion to treat anaemia towards a higher level.
To treat Hb to a higher level a choice can be made to correct Hb when it has dropped to a very low level after renal disease has reached an advanced stage or alternatively to prevent anaemia in an early stage of renal disease. In an analysis of the normal hematocrit trial, Macdougall and Ritz suggest the latter. This is the main purpose of this trial.
Treatment with Epoetin alfa also makes patients feel better physically when their exercise capacity improves. During treatment with Epoetin alfa, several secondary effects may simultaneously influence the maximal exercise capacity after correction of the anaemia. The improved well-being may result in an increase in physical activity and exercise capacity can be further improved by such conditioning. The improved oxygen transport after correction of anaemia reverses the circulatory adaptation to hypoxia and most studies have shown a decrease in cardiac output at rest, and an increase in peripheral resistance. However, approximately one-third of chronic renal failure patients treated with Epoetin alfa have episodes of hypertension, and may require increased doses of anti-hypertensive medication.
This prospective study will assess whether maintaining Hb levels at normal or sub-normal levels can influence the health status, left ventricular mass and quality of life (QoL) of early renal insufficiency subjects without additional safety concerns. The patients will receive Epoetin Alfa as subcutaneous or intravenous injections in variable dosages for a maximum of 42 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with early renal insufficiency who are not on haemodialysis
- A baseline Hb level of >7.5 mmol/l (120 g/l) but expected to decrease during the coming months. Allowed exceptions: Hb < 7,5 mmol/l (120 g/l) for a maximum of 6 months. In medical history an Hb < 7,0 mmol/l (113 g/l) is only allowed for a maximum period of 3 months and in relation to an accidental drop in Hb (f.e. caused by surgery, gastric bleeding etc.)
- Age: 18 - 73 years, given that patients >70 years are in good general condition and are expected to complete the 30 months study period
- Creatinine clearance < 40 ml/min/1.73 m2 (Cockcroft formula) or creatinin clearance < 50 ml/min/1.73 m2), given that the clearance and Hb show a downward tendency as demonstrated in the patient files and medical history
Key exclusion criteria (9 listed)
- Presence of clinically significant disease/dysfunction of hepatic, pulmonary, hematological (e.g. sickle cell anaemia, thalassemia, major myelodysplastic syndromes, hemolytic anaemia), neurological, musculo-skeletal, endocrine, gastrointestinal or genitourinary system unrelated to underlying chronic renal failure which in the opinion of the investigator would disqualify the patient from this study
- Cystic kidney disease
- Clinical or laboratory evidence of untreated iron, folate or Vitamin B12 deficiency
- Presence of concomitant malignancy (other than basal cell carcinoma of the skin)
- Uncontrolled hypertension (i.e. diastolic blood pressure of > 100 mm Hg)
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 Alfa | Drug | – |
Primary outcome
Absolute change in left ventricular mass index
1 secondary outcome
Incidence of Left Ventricular hypertrophy QoL assessment (FACIT-Fatigue Scale and KDQOL-SFÒ) The change in pulse pressure during the study period. Morbidity and mortality during the study-period Deterioration of renal function Days in hospital
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 1 Feb 2011.
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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.
Janssen-Cilag B.V. Clinical Trial study director
Janssen-Cilag B.V.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin Alfa in people with Anemia, run by Janssen-Cilag B.V..
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 4 inclusion and 9 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 1 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Absolute change in left ventricular mass index. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2011.