AnemiaNCT03803514
Effect of rEPO in FGF23 in ESRD Patients
An observational study of Anemia and Chronic Kidney Diseases, run by University of Chile at 1 site in Chile.
Trial summary
Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in hemodialysis. Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO therapy were compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Chronic Kidney Diseases
- What is being tested?
- Recombinant EPO
- How many people
- 60 participants
- Where
- 1 siteChile
- Study dates
- 15 Aug 2017to 20 Oct 2019
- 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: Pacients in chronic hemodialysis, will be measured with FGF23 levels
Who may be able to join
- End-Stage Renal Disease
- Requirements of Hemodialysis
- At least 6 months since initiation of hemodialysis
Who cannot join
- Pregnancy
- Treatment with rhEPO or analogs during the previous 6 months or earlier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in hemodialysis.
Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO therapy were compared. Measurements of plasma FGF23 were performed at baseline and during the complete study. Demographic, clinical and laboratory data will be obtained.
Follow-up period: 12 weeks.
Read the detailed description
Experimental data has shown that recombinant erythropoietin (rEPO) increases plasma levels of Fibroblast Growth Factor 23 (FGF23) in murines, both health and with acute or chronic renal disease. Also, observational studies indicate an association between EPO and FGF23 levels in patients. Until now, it has not been demonstrated whether the use of rEPO does increase plasma FGF23 in End-Stage Renal Disease (ESRD) patients in hemodialysis (a population with a high use of this therapy for the management of chronic anemia).
Our objective was to evaluate whether the administration of rEPO increases plasma FGF23 levels in ESRD patients in hemodialysis.
We performed a prospective cohort with ESRD patients without rEPO therapy. We performed 2 groups: patients with requirements of rEPO therapy due to anemia (Hb < 10 g/dL) and patients without rEPO therapy (Hb > 10 g/dL).
We measured plasma FGF23 (intact and C-terminal) at baseline and during 12 weeks.
Demographic, clinical and laboratory data was obtained. Patients treated with rEPO received beta-epoetin (Recormon, Roche), according to current recommendations.
Patients were follow-up during 3 months to evaluate the effects of rEPO. Our primary outcome was changes in plasma intact FGF23 at 12 weeks, between both groups.
- Conditions
- Anemia, Chronic Kidney Diseases
- Being tested
- Recombinant EPO
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant EPODrug
Also called rEPO
Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Treated group (rEPO) | Patients with ESRD in HD, and medical indication of recombinant EPO for management of anemia (Hb < 10 g/dL). Ambulatory hemodialysis 3 times per week.
Recombinant beta-epoetin (Recormon) will be used, according to current recommendations.
Clinical and laboratory data will be obtained before and during the study. The primary outcome (changes of plasma intact FGF23) will be measured during the follow-up, up to 12 weeks. Receives: Drug: Recombinant EPO | |
| Control group | Patients with ESRD and HD, without medical indication of recombinant EPO (Hb > 10 g/dL). Ambulatory hemodialysis 3 times per week. Follow-up for 3 months, similar than rEPO group. Clinical and laboratory data will be obtained before and during the study, similar periods than rEPO group. The primary outcome (changes of plasma FGF23) will be measured every 2 week during the evaluation period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma intact FGF23 levels
Measurements of plasma intact FGF23 levels
Measured: 12 weeks
Secondary outcomes (3)
Changes in plasma C-terminal FGF23 levels
Measurements of plasma C-terminal FGF23 levels
Measured: 12 weeks
Changes in hematocrit and hemoglobin
Measurements of hematocrit and hemoglobin in blood samples
Measured: 12 weeks
Changes in parathormone levels
Measurements of parathormone levels in blood samples
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start15 Aug 2017
- Primary completion31 Mar 2019
- Study completion20 Oct 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Toro, University of Chile
- Investigators
- Luis Michea, MD PhD, Study chair, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803514
- Sponsor's protocol ID
- ID-11102-23
- Status last verified
- May 2020
- First submitted
- 10 Jan 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Recombinant Erythropoietin in Plasma Levels of FGF23 in End-Stage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT03803514
- Acronym / sponsor ID
- ID-11102-23
- Conditions
- Anemia, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 14 Jan 2019 (actual)
- 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.
Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in hemodialysis.
Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO therapy were compared. Measurements of plasma FGF23 were performed at baseline and during the complete study. Demographic, clinical and laboratory data will be obtained.
Follow-up period: 12 weeks.
Detailed description
Experimental data has shown that recombinant erythropoietin (rEPO) increases plasma levels of Fibroblast Growth Factor 23 (FGF23) in murines, both health and with acute or chronic renal disease. Also, observational studies indicate an association between EPO and FGF23 levels in patients. Until now, it has not been demonstrated whether the use of rEPO does increase plasma FGF23 in End-Stage Renal Disease (ESRD) patients in hemodialysis (a population with a high use of this therapy for the management of chronic anemia).
Our objective was to evaluate whether the administration of rEPO increases plasma FGF23 levels in ESRD patients in hemodialysis.
We performed a prospective cohort with ESRD patients without rEPO therapy. We performed 2 groups: patients with requirements of rEPO therapy due to anemia (Hb < 10 g/dL) and patients without rEPO therapy (Hb > 10 g/dL).
We measured plasma FGF23 (intact and C-terminal) at baseline and during 12 weeks.
Demographic, clinical and laboratory data was obtained. Patients treated with rEPO received beta-epoetin (Recormon, Roche), according to current recommendations.
Patients were follow-up during 3 months to evaluate the effects of rEPO. Our primary outcome was changes in plasma intact FGF23 at 12 weeks, between both groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated group (rEPO) | – | Drug: Recombinant EPOPatients with ESRD in HD, and medical indication of recombinant EPO for management of anemia (Hb < 10 g/dL). Ambulatory hemodialysis 3 times per week. Recombinant beta-epoetin (Recormon) will be used, according to current recommendations. Clinical and laboratory data will be obtained before and during the study. The primary outcome (changes of plasma intact FGF23) will be measured during the follow-up, up to 12 weeks. |
| Control group | – | –Patients with ESRD and HD, without medical indication of recombinant EPO (Hb > 10 g/dL). Ambulatory hemodialysis 3 times per week. Follow-up for 3 months, similar than rEPO group. Clinical and laboratory data will be obtained before and during the study, similar periods than rEPO group. The primary outcome (changes of plasma FGF23) will be measured every 2 week during the evaluation period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pacients in chronic hemodialysis, will be measured with FGF23 levels
Key inclusion criteria (3 listed)
- End-Stage Renal Disease
- Requirements of Hemodialysis
- At least 6 months since initiation of hemodialysis
Key exclusion criteria (2 listed)
- Pregnancy
- Treatment with rhEPO or analogs during the previous 6 months or earlier
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 |
|---|---|---|
| Recombinant EPOAlso: rEPOBeta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations. | Drug | Treated group (rEPO) |
Primary outcome
Changes in plasma intact FGF23 levels
Time frame: 12 weeks
Measurements of plasma intact FGF23 levels
3 secondary outcomes
Changes in plasma C-terminal FGF23 levels
Time frame: 12 weeks
Changes in hematocrit and hemoglobin
Time frame: 12 weeks
Changes in parathormone levels
Time frame: 12 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 27 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Luis Michea, MD PhD study chair
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Chronic Kidney Diseases, run by University of Chile at 1 site in Chile.
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 3 inclusion and 2 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 27 May 2020. 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 Chile. 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 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?
Changes in plasma intact FGF23 levels (time frame: 12 weeks). 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 27 May 2020.