Red-Cell Aplasia, PureNCT00211029
A Study to Observe the Number of Patients Who Develop Pure Red Cell Aplasia (PRCA, a Rare Form of Anemia) While Receiving Epoetin Alfa or Other Recombinant Erythropoietins
An observational study of Red-Cell Aplasia, Pure, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to record the number of participants with chronic renal disease who are receiving treatment with epoetin alfa or other recombinant erythropoietins who develop pure red cell aplasia (PRCA, a rare form of anemia) during the study period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Red-Cell Aplasia, Pure
- How many people
- 4,670 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jul 2005
- Phase
- Observational
- 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
Study population: Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins.
Who may be able to join
- Male or female patients of legal age to give consent according to local standards
- Patients must be receiving or about to receive treatment with an erythropoietin as part of a pre-existing treatment plan for their chronic renal (or other) disease
- Physicians treating the patients must agree in advance to document any appearance of pure red cell aplasia (PRCA) such that information and details of the case may be reported to regulatory agencies (with patient identification protected)
- If required by local ethics committees, patients must give consent to permit the collection of de-identified personal data for the specific purpose of this study
Who cannot join
- Patients who are unable to complete future follow-up visits
- Patients who when entering the study have any of the following symptoms of pure red cell aplasia (PRCA): Loss of effectiveness of erythropoietin or low number of immature red blood cells while on erythropoietin as shown by a blood test or bone marrow examination
- Patients with a history of PRCA or loss of effectiveness with erythropoietin at the time of enrollment into the study
- Patients whose anemia did not respond to previous treatment with an erythropoietin
- Patients with a history of antibodies to erythropoietin prior to entering the study
About this study
Official title: An Active Safety Surveillance Plan to Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa Therapy or Other Recombinant Erythropoietins
The purpose of this study is to record the number of participants with chronic renal disease who are receiving treatment with epoetin alfa or other recombinant erythropoietins who develop pure red cell aplasia (PRCA, a rare form of anemia) during the study period.
Read the detailed description
This is a prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions) and cohort study. Study specific information will be collected from participants with chronic renal disease who are receiving recombinant erythropoietin and their treatment course will be followed for up to 2 years and participants will not receive any intervention in this study. Upon entering the study, information will be collected regarding disease history and recombinant erythropoietin treatment. Every 3 months thereafter, progress information will be collected, including recombinant erythropoietin treatment, number of red blood cells and presence of any signs of pure red cell aplasia (PRCA) development. The results of this study will be combined with a similar study (EPO-IMU-402) that also collects blood samples to observe the number of patients who develop antibodies to erythropoietin. Participants discontinuing erythropoietin will be followed only for an additional 12 months from the time erythropoietin is discontinued. Participants will receive standard-of-care treatment for their chronic renal disease from their individual Investigators. Participants will be primarily observed prospectively for PRCA. The study hypothesis is that these data will provide a framework for the expansion of the patient population to estimate the incidence of PRCA associated with the use of epoetin alfa or other recombinant erythropoietins for other therapeutic indications.
- Conditions
- Red-Cell Aplasia, Pure
- Keywords
- Anemia, Hemoglobin, Red Blood Cells, Epoetin alfa, Epoetin, erythropoietin, Red Cell Aplasia, Pure Red Cell Aplasia, Chronic Renal Failure, Kidney Failure
- Medical subject headings
- Red-Cell Aplasia, Pure, Anemia, Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving Epoetin Alfa or Another Erythropoietin | Participants will not receive any intervention in this study. Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins will be prospectively observed to monitor incidence of pure red cell aplasia and/or antibodies to erythropoietin. Participants will receive standard-of-care treatment for their chronic renal (or other) disease from their individual Investigators. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Pure Red Cell Aplasia (PRCA)
The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.
Measured: Up to 2 years
Number of Participants With Positive Serum Erythropoietin (EPO) Antibodies Development Associated With Different Routes of Administration
Antibodies are immunoglobulin molecules having a specific amino acid sequence by virtue of which they interact only with the antigen (or a very similar shape) that induced their synthesis in cells of the lymphoid series.
Measured: Up to 2 years
Relationship between EPO Antibodies and PRCA
Natural history of EPO antibodies will be examined and its relationship to PRCA will be checked.
Measured: Up to 2 years
Secondary outcomes (3)
Number of Participants With Pure Red Cell Aplasia (PRCA) Associated With Different Routes of Administration
The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.
Measured: Every 3 Months up to up to 2 years
Change From Baseline in Number of Participants With PRCA Over Time
The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.
Measured: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24
Number of Participants With Pure Red Cell Aplasia (PRCA) and non-PRCA
Data will be collected from PRCA cases and non-PRCA cases to assist with identification of risk factors for PRCA such as demographic profile and duration of exposure to epoetin alfa or other recombinant erythropoietins.
Measured: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red-Cell Aplasia, PureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211029
- Sponsor's protocol ID
- CR004405
- Other IDs
- EPO-IMU-401
- Status last verified
- Jul 2015
- First submitted
- 13 Sep 2005
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Active Safety Surveillance Plan to Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa Therapy or Other Recombinant Erythropoietins
- ClinicalTrials.gov ID
- NCT00211029
- Acronym / sponsor ID
- CR004405
- Conditions
- Red-Cell Aplasia, Pure
- Keywords
- Anemia, Hemoglobin, Red Blood Cells, Epoetin alfa, Epoetin, erythropoietin, Red Cell Aplasia, Pure Red Cell Aplasia, Chronic Renal Failure, Kidney Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,670 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 21 Sep 2005 (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 record the number of participants with chronic renal disease who are receiving treatment with epoetin alfa or other recombinant erythropoietins who develop pure red cell aplasia (PRCA, a rare form of anemia) during the study period.
Detailed description
This is a prospective (observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions) and cohort study. Study specific information will be collected from participants with chronic renal disease who are receiving recombinant erythropoietin and their treatment course will be followed for up to 2 years and participants will not receive any intervention in this study. Upon entering the study, information will be collected regarding disease history and recombinant erythropoietin treatment. Every 3 months thereafter, progress information will be collected, including recombinant erythropoietin treatment, number of red blood cells and presence of any signs of pure red cell aplasia (PRCA) development. The results of this study will be combined with a similar study (EPO-IMU-402) that also collects blood samples to observe the number of patients who develop antibodies to erythropoietin. Participants discontinuing erythropoietin will be followed only for an additional 12 months from the time erythropoietin is discontinued. Participants will receive standard-of-care treatment for their chronic renal disease from their individual Investigators. Participants will be primarily observed prospectively for PRCA. The study hypothesis is that these data will provide a framework for the expansion of the patient population to estimate the incidence of PRCA associated with the use of epoetin alfa or other recombinant erythropoietins for other therapeutic indications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving Epoetin Alfa or Another Erythropoietin | – | –Participants will not receive any intervention in this study. Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins will be prospectively observed to monitor incidence of pure red cell aplasia and/or antibodies to erythropoietin. Participants will receive standard-of-care treatment for their chronic renal (or other) disease from their individual Investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic renal disease receiving treatment with epoetin alfa or other recombinant erythropoietins.
Key inclusion criteria (4 listed)
- Male or female patients of legal age to give consent according to local standards
- Patients must be receiving or about to receive treatment with an erythropoietin as part of a pre-existing treatment plan for their chronic renal (or other) disease
- Physicians treating the patients must agree in advance to document any appearance of pure red cell aplasia (PRCA) such that information and details of the case may be reported to regulatory agencies (with patient identification protected)
- If required by local ethics committees, patients must give consent to permit the collection of de-identified personal data for the specific purpose of this study
Key exclusion criteria (5 listed)
- Patients who are unable to complete future follow-up visits
- Patients who when entering the study have any of the following symptoms of pure red cell aplasia (PRCA): Loss of effectiveness of erythropoietin or low number of immature red blood cells while on erythropoietin as shown by a blood test or bone marrow examination
- Patients with a history of PRCA or loss of effectiveness with erythropoietin at the time of enrollment into the study
- Patients whose anemia did not respond to previous treatment with an erythropoietin
- Patients with a history of antibodies to erythropoietin prior to entering the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Pure Red Cell Aplasia (PRCA)
Time frame: Up to 2 years
The PRCA is the suppression of erythropoiesis with little or no abnormality of leukocyte or platelet production.
Number of Participants With Positive Serum Erythropoietin (EPO) Antibodies Development Associated With Different Routes of Administration
Time frame: Up to 2 years
Antibodies are immunoglobulin molecules having a specific amino acid sequence by virtue of which they interact only with the antigen (or a very similar shape) that induced their synthesis in cells of the lymphoid series.
Relationship between EPO Antibodies and PRCA
Time frame: Up to 2 years
Natural history of EPO antibodies will be examined and its relationship to PRCA will be checked.
3 secondary outcomes
Number of Participants With Pure Red Cell Aplasia (PRCA) Associated With Different Routes of Administration
Time frame: Every 3 Months up to up to 2 years
Change From Baseline in Number of Participants With PRCA Over Time
Time frame: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24
Number of Participants With Pure Red Cell Aplasia (PRCA) and non-PRCA
Time frame: Baseline and Month 3, 6, 9, 12, 15, 18, 21, 24
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 31 Jul 2015.
- An Active Safety Surveillance Plan to Prospectively Monitor the Incidence of Pure Red Cell Aplasia (PRCA) Among Patients Receiving Epoetin Alfa Therapy or Other ErythropoietinsLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
An observational study of Red-Cell Aplasia, Pure, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 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 31 Jul 2015. 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.
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?
Number of Participants With Pure Red Cell Aplasia (PRCA) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. 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 31 Jul 2015.