AnemiaNCT01290328
Study of Epoetin Alfa to Treat Anemia After Kidney Transplantation
A study testing Epoetin Alfa in people with Anemia, run by Mehrotra, Anita, M.D. at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the effect of Epoetin Alfa (Procrit) on the change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. The investigators hypothesize that epoetin alfa will raise hemoglobin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Epoetin Alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Apr 2014
- Phase
- Interventional
- 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
- Age > 18 years
- Kidney transplant recipient at least 8 weeks post-transplant
- Mild to moderate anemia, defined as 9.0 g/dL < Hb < 11 g/dL)
- Estimated GFR (by MDRD) < 60 mL/min (not on dialysis)
- Transferrin saturation > 20% and Ferritin > 100 ng/mL
Who cannot join
- History of erythrocyte-stimulating agent (ESA) use in the previous 8 weeks
- Red blood cell transfusion in previous 30 days
- History of HIV/AIDS
- Nonfunctioning graft, defined as patient requiring chronic dialysis
- Hypersensitivity to ESAs or albumin
- Uncontrolled hypertension, defined as screening BP > 180/100
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- New-onset seizures (diagnosed within the last 3 months) or seizure disorder uncontrolled on medications (breakthrough seizures on medication)
- History of any neoplasm except: adequately treated basal or squamous cell carcinoma of the skin, solid tumors (except primary CNS lymphoma) treated with curative therapy and disease-free for more than 5 years.
- Pregnancy or lactating
- Vitamin B12 deficiency (Vit B12 < 180 pg/mL)
- Untreated folate deficiency (folate < 6.6 ng/mL)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: Epoetin Alfa in the Treatment of Post-Transplant Anemia: A Randomized Controlled Trial
The primary purpose of this study is to determine the effect of Epoetin Alfa (Procrit) on the change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. The investigators hypothesize that epoetin alfa will raise hemoglobin.
Read the detailed description
Anemia has become an increasingly recognized problem in kidney transplant recipients, and erythropoietin is often prescribed as treatment despite limited data regarding outcomes. Multiple clinical trials have demonstrated correction of anemia with erythropoietin in patients with chronic kidney disease (pre-transplant) and patients on dialysis. No large clinical trials of erythropoietin treatment have been done in anemic kidney transplant recipients, however. The investigators hypothesize that when used for the treatment of post-transplant anemia, Epoetin Alfa increases hemoglobin (Hb). The investigators further hypothesize that Epoetin Alfa suppresses pathogenic alloimmunity directed at the kidney transplant and as a consequence, prevents immune-mediated injury and thereby preserves renal function. Finally, the investigators hypothesize that treatment of post-transplant anemia with Epoetin Alfa also results in improved patient-reported outcomes (quality of life) and decreased left ventricular mass. In order to test these hypotheses, the investigators propose a randomized controlled trial of Epoetin Alfa in anemic kidney transplant recipients (9.0 < Hb < 11.0). 100 study subjects will be randomized to either treatment with Epoetin Alfa at a starting dose of 150 units/kg/week or no treatment (50 subjects/arm). The primary outcome of change in Hb will be measured by CBC at 6 weeks, 3 months, 6 months, and 1 year of enrollment. Secondary outcomes to be measured include change in renal function (eGFR), change in T cell phenotype, change in patient-reported outcomes (SF-36 form), and change in left ventricular mass (by cardiac MRI).
- Conditions
- Anemia
- Being tested
- Epoetin Alfa
- Keywords
- anemia, kidney transplant, alloimmunity
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin AlfaDrug
Also called Procrit
150 units/kg/weekly
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Not described |
| Epoetin alfa | Experimental | 150 units/kg/week Receives: Drug: Epoetin Alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in hemoglobin
The primary outcome of change in Hb will be measured by CBC at 6 weeks, 3 months, 6 months, and 1 year of enrollment.
Measured: 6 weeks to 1 year
Secondary outcomes (1)
change in renal function (eGFR)
Measured: 6 weeks to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Why it stopped: low enrollment, termination of funding
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mehrotra, Anita, M.D.
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Anita Mehrotra MD, Mehrotra, Anita, M.D.
- Investigators
- Anita Mehrotra, MD, Study director, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290328
- Sponsor's protocol ID
- 10-0843
- Other IDs
- EPONAP2001
- Status last verified
- Jul 2012
- First submitted
- 3 Feb 2011
- Last updated
- 27 Feb 2014
- 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 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epoetin Alfa in the Treatment of Post-Transplant Anemia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01290328
- Acronym / sponsor ID
- 10-0843
- Conditions
- Anemia
- Keywords
- anemia, kidney transplant, alloimmunity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment, termination of funding
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mehrotra, Anita, M.D.
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Feb 2011
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 7 Feb 2011 (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 primary purpose of this study is to determine the effect of Epoetin Alfa (Procrit) on the change in hemoglobin (red blood cell count) in anemic kidney transplant recipients. The investigators hypothesize that epoetin alfa will raise hemoglobin.
Detailed description
Anemia has become an increasingly recognized problem in kidney transplant recipients, and erythropoietin is often prescribed as treatment despite limited data regarding outcomes. Multiple clinical trials have demonstrated correction of anemia with erythropoietin in patients with chronic kidney disease (pre-transplant) and patients on dialysis. No large clinical trials of erythropoietin treatment have been done in anemic kidney transplant recipients, however. The investigators hypothesize that when used for the treatment of post-transplant anemia, Epoetin Alfa increases hemoglobin (Hb). The investigators further hypothesize that Epoetin Alfa suppresses pathogenic alloimmunity directed at the kidney transplant and as a consequence, prevents immune-mediated injury and thereby preserves renal function. Finally, the investigators hypothesize that treatment of post-transplant anemia with Epoetin Alfa also results in improved patient-reported outcomes (quality of life) and decreased left ventricular mass. In order to test these hypotheses, the investigators propose a randomized controlled trial of Epoetin Alfa in anemic kidney transplant recipients (9.0 < Hb < 11.0). 100 study subjects will be randomized to either treatment with Epoetin Alfa at a starting dose of 150 units/kg/week or no treatment (50 subjects/arm). The primary outcome of change in Hb will be measured by CBC at 6 weeks, 3 months, 6 months, and 1 year of enrollment. Secondary outcomes to be measured include change in renal function (eGFR), change in T cell phenotype, change in patient-reported outcomes (SF-36 form), and change in left ventricular mass (by cardiac MRI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | – |
| Epoetin alfa | Experimental | Drug: Epoetin Alfa150 units/kg/week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Kidney transplant recipient at least 8 weeks post-transplant
- Mild to moderate anemia, defined as 9.0 g/dL < Hb < 11 g/dL)
- Estimated GFR (by MDRD) < 60 mL/min (not on dialysis)
- Transferrin saturation > 20% and Ferritin > 100 ng/mL
Key exclusion criteria (11 listed)
- History of erythrocyte-stimulating agent (ESA) use in the previous 8 weeks
- Red blood cell transfusion in previous 30 days
- History of HIV/AIDS
- Nonfunctioning graft, defined as patient requiring chronic dialysis
- Hypersensitivity to ESAs or albumin
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 AlfaAlso: Procrit150 units/kg/weekly | Drug | Epoetin alfa |
Primary outcome
change in hemoglobin
Time frame: 6 weeks to 1 year
The primary outcome of change in Hb will be measured by CBC at 6 weeks, 3 months, 6 months, and 1 year of enrollment.
1 secondary outcome
change in renal function (eGFR)
Time frame: 6 weeks to 1 year
Results and safety
The study was stopped early (reason given: low enrollment, termination of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- 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.
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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.
Anita Mehrotra, MD study director
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epoetin Alfa in people with Anemia, run by Mehrotra, Anita, M.D. at 1 site in United States.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 27 Feb 2014. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: low enrollment, termination of funding). Results are not available in the source record.
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?
change in hemoglobin (time frame: 6 weeks to 1 year). 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 NCT01290328, 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 27 Feb 2014.