AnemiaPhase 4PIERAIDNCT02876211
Paricalcitol Improves Anemia of Inflammation
A Phase 4 study testing Paricalcitol and Epoetin beta in people with Anemia, run by Hospital Son Espases at 1 site in Spain.
Trial summary
Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is a selective vitamin D receptor activator with potential benefits on anti-inflammatory cytokines expression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Paricalcitol and Epoetin beta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2014to Dec 2024
- 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
- Age >= 18 years.
- Patients with CKD on hemodialysis of any etiology..
- Hemoglobin between 9 and 12g/dl at least 12 weeks before enrollment in the study.
- Hemoglobin plasma levels stabilized: Hb variation <or = 1 g / dl for the two months prior to inclusion in the study.
- Patients with anemia of renal etiology.
- ESA treatment with stable doses for 2 months prior to baseline.Stable dose ESA Definition: Variation <or = 3000UI/week.
Show all 12Show fewer
- Iron status: Ferritin> 200 ng / mL and/or transferrin saturation index (IST):> = 20%).
- KT / V >= 1.2 ( Daugirdas-2nd generation).
- Calcium concentrations between : 8.4 to 9.5 mg / dl and phosphorus: 3.5-5.5 mg / dl.
- Vitamin D 25OH normal >= 15 ng / ml (patients with lower levels will be supplemented with calcifediol 16000 IU / bi-weekly for 6 weeks in selected patients).
- PTHi concentrations> = 150 pg / mL and <or = to 300 pg / ml.
- Patients who accept their inclusion in the study and sign informed consent.
Who cannot join
- Epoetin beta dose > 18,000 IU / weekly.
- Pregnant woman of childbearing age or gestational wishes or not to use adequate contraception ( the Ogino-Knaus contraceptive method is considered unsuitable).
- Active bleeding episode or history of transfusion the 2 months prior to baseline.
- Patients with non-renal causes of anemia: malignancies, folic acid or vitamin B12 deficiency, hemoglobinopathies, hemolysis, pure red cell aplasia secondary to erythropoietin.
- Patients treated with the selective vitamin D receptor activator in the 3 months prior to inclusion in the study.
- Acute or chronic symptomatic: heart failure (IV-NYHA), infection or inflammatory disease, uncontrolled hypertension that requires the suspension of epoetin beta, thrombocytopathies, aplastic anemia.
- Immunosuppressive treatment with uncontrolled Hemoglobin level
- Allergy to paricalcitol or any of its components.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Son Espases University Hospital
Palma de Mallorca, Balearic Islands, 07120
About this study
Official title: Benefits of the Paricalcitol (Selective Vitamin D Receptor Activator) on Anemia of Inflammation in Dialysis Patients Under Erythropoiesis-stimulating Agents Treatment.
Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is a selective vitamin D receptor activator with potential benefits on anti-inflammatory cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.
Read the detailed description
Anemia of inflammation and secondary hyperparathyroidism (SHPT) are two common clinical complications in patients with chronic kidney disease. Eryptosis (accelerated red blood cell death) is a novel mechanism associated with renal anemia and several factors such us iron, erythropoietin and klotho (anti-aging hormone) deficiency have been associated with this process.
The use of the paricalcitol may inhibit pro-inflammatory cytokines expression, especially interleukine-6, which is one of the most important cytokine associated with the pathogenesis of the AI. If the use of the paricalcitol for the SHPT control may exert direct influence on the erythropoiesis process is not known.
- Conditions
- Anemia
- Being tested
- Paricalcitol, Epoetin beta, Placebo
- Keywords
- Renal disease, Erythropoiesis, Erythropoietin stimulating agent, Iron, Klotho, Selective vitamin D receptor activation
- Medical subject headings
- Anemia, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Also called Selective vitamin D receptor activation
Paricalcitol 2 capsules/three times per week
Epoetin betaDrug
Also called anti-anemic drug
epoetin 1-3 times per week
PlaceboDrug
Placebo 2 capsules/three times per week
| Study group | Role | What they receive |
|---|---|---|
| paricalcitol plus epoetin beta | Experimental | Paricalcitol 2 capsules /three times per week \& epoetin Receives: Drug: Paricalcitol; Drug: Epoetin beta |
| placebo plus epoetin beta | Placebo comparator | Placebo 2 capsules/three times per week \& epoetin Receives: Drug: Epoetin beta; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ESA dosage
Percentage of ESA doses after 6 months of the paricalcitol or placebo administration.
Measured: 6 months
Secondary outcomes (8)
Changes on ferrokinetics.
Changes on serum iron, transferrin, ferritin, transferrin saturation and red cell distribution width at month 6.
Measured: 6 months
Changes on interleukin-6 plasma levels.
Changes on pg/ml
Measured: 6 months
Changes on hepcidin plasma levels.
Changes on pg/ml
Measured: 6 months
Changes on erythropoietin plasma levels.
Changes on mUI/ml
Measured: 6 months
Changes on systolic blood pressure.
Changes in mmHg determined by 24 hours ambulatory blood pressure monitoring.
Measured: 6 months
Changes on diastolic blood pressure.
Changes in mmHg determined by 24 hours ambulatory blood pressure monitoring.
Measured: 6 months
Cardiovascular serious adverse events in each arm of treatment.
Cardiac arrest, angina pectoris. Stroke.
Measured: 6 months
Adverse events related to vascular access disfunction.
Arteriovenous fistula site hemorrhage or thrombosis. Catheter disfunction.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startDec 2014
- Primary completionAug 2022
- Study completionDec 2024
Why it stopped: Difficult inclusion of patients diagnosed with renal anemia in chronic hemodialysis patients without hyperparathyroidism.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Son Espases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Giovanni Uriol Rivera, Hospital Son Espases
- Investigators
- Miguel Uriol, Ph.D.M.D., Principal investigator, Son Espases University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876211
- Sponsor's protocol ID
- PIERAID-2013
- Acronym
- PIERAID
- Status last verified
- Dec 2024
- First submitted
- 12 Aug 2016
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The IPD could be shared with any interested public research institute
Publications
Sun CC, Vaja V, Babitt JL, Lin HY. Targeting the hepcidin-ferroportin axis to develop new treatment strategies for anemia of chronic disease and anemia of inflammation. Am J Hematol. 2012 Apr;87(4):392-400. doi: 10.1002/ajh.23110. Epub 2012 Jan 31.
PubMed 22290531Perlstein TS, Pande R, Berliner N, Vanasse GJ. Prevalence of 25-hydroxyvitamin D deficiency in subgroups of elderly persons with anemia: association with anemia of inflammation. Blood. 2011 Mar 10;117(10):2800-6. doi: 10.1182/blood-2010-09-309708. Epub 2011 Jan 14.
PubMed 21239700Kempe DS, Ackermann TF, Fischer SS, Koka S, Boini KM, Mahmud H, Foller M, Rosenblatt KP, Kuro-O M, Lang F. Accelerated suicidal erythrocyte death in Klotho-deficient mice. Pflugers Arch. 2009 Jul;458(3):503-12. doi: 10.1007/s00424-009-0636-4. Epub 2009 Jan 28.
PubMed 19184092
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of the Paricalcitol (Selective Vitamin D Receptor Activator) on Anemia of Inflammation in Dialysis Patients Under Erythropoiesis-stimulating Agents Treatment.
- ClinicalTrials.gov ID
- NCT02876211
- Acronym / sponsor ID
- PIERAID / PIERAID-2013
- Conditions
- Anemia
- Keywords
- Renal disease, Erythropoiesis, Erythropoietin stimulating agent, Iron, Klotho, Selective vitamin D receptor activation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult inclusion of patients diagnosed with renal anemia in chronic hemodialysis patients without hyperparathyroidism.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospital Son EspasesUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Dec 2024 (actual)
- First posted
- 23 Aug 2016 (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.
Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is a selective vitamin D receptor activator with potential benefits on anti-inflammatory cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.
Detailed description
Anemia of inflammation and secondary hyperparathyroidism (SHPT) are two common clinical complications in patients with chronic kidney disease. Eryptosis (accelerated red blood cell death) is a novel mechanism associated with renal anemia and several factors such us iron, erythropoietin and klotho (anti-aging hormone) deficiency have been associated with this process.
The use of the paricalcitol may inhibit pro-inflammatory cytokines expression, especially interleukine-6, which is one of the most important cytokine associated with the pathogenesis of the AI. If the use of the paricalcitol for the SHPT control may exert direct influence on the erythropoiesis process is not known.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paricalcitol plus epoetin beta | Experimental | Drug: Paricalcitol, Drug: Epoetin betaParicalcitol 2 capsules /three times per week \& epoetin |
| placebo plus epoetin beta | Placebo comparator | Drug: Epoetin beta, Drug: PlaceboPlacebo 2 capsules/three times per week \& epoetin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age >= 18 years.
- Patients with CKD on hemodialysis of any etiology..
- Hemoglobin between 9 and 12g/dl at least 12 weeks before enrollment in the study.
- Hemoglobin plasma levels stabilized: Hb variation <or = 1 g / dl for the two months prior to inclusion in the study.
- Patients with anemia of renal etiology.
Key exclusion criteria (8 listed)
- Epoetin beta dose > 18,000 IU / weekly.
- Pregnant woman of childbearing age or gestational wishes or not to use adequate contraception ( the Ogino-Knaus contraceptive method is considered unsuitable).
- Active bleeding episode or history of transfusion the 2 months prior to baseline.
- Patients with non-renal causes of anemia: malignancies, folic acid or vitamin B12 deficiency, hemoglobinopathies, hemolysis, pure red cell aplasia secondary to erythropoietin.
- Patients treated with the selective vitamin D receptor activator in the 3 months prior to inclusion in 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParicalcitolAlso: Selective vitamin D receptor activationParicalcitol 2 capsules/three times per week | Drug | paricalcitol plus epoetin beta |
| Epoetin betaAlso: anti-anemic drugepoetin 1-3 times per week | Drug | paricalcitol plus epoetin beta, placebo plus epoetin beta |
| PlaceboPlacebo 2 capsules/three times per week | Drug | placebo plus epoetin beta |
Primary outcome
Changes in ESA dosage
Time frame: 6 months
Percentage of ESA doses after 6 months of the paricalcitol or placebo administration.
8 secondary outcomes
Changes on ferrokinetics.
Time frame: 6 months
Changes on interleukin-6 plasma levels.
Time frame: 6 months
Changes on hepcidin plasma levels.
Time frame: 6 months
Changes on erythropoietin plasma levels.
Time frame: 6 months
Changes on systolic blood pressure.
Time frame: 6 months
Changes on diastolic blood pressure.
Time frame: 6 months
Cardiovascular serious adverse events in each arm of treatment.
Time frame: 6 months
Adverse events related to vascular access disfunction.
Time frame: 6 month
Results and safety
The study was stopped early (reason given: Difficult inclusion of patients diagnosed with renal anemia in chronic hemodialysis patients without hyperparathyroidism.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Background: PubMed 22290531Sun CC, Vaja V, Babitt JL, Lin HY. Targeting the hepcidin-ferroportin axis to develop new treatment strategies for anemia of chronic disease and anemia of inflammation. Am J Hematol. 2012 Apr;87(4):392-400. doi: 10.1002/ajh.23110. Epub 2012 Jan 31.
- Background: PubMed 21239700Perlstein TS, Pande R, Berliner N, Vanasse GJ. Prevalence of 25-hydroxyvitamin D deficiency in subgroups of elderly persons with anemia: association with anemia of inflammation. Blood. 2011 Mar 10;117(10):2800-6. doi: 10.1182/blood-2010-09-309708. Epub 2011 Jan 14.
- Background: PubMed 19184092Kempe DS, Ackermann TF, Fischer SS, Koka S, Boini KM, Mahmud H, Foller M, Rosenblatt KP, Kuro-O M, Lang F. Accelerated suicidal erythrocyte death in Klotho-deficient mice. Pflugers Arch. 2009 Jul;458(3):503-12. doi: 10.1007/s00424-009-0636-4. Epub 2009 Jan 28.
- Individual participant dataSharing planned: Yes. The IPD could be shared with any interested public research institute
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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.
Miguel Uriol, Ph.D.M.D. principal investigator
Son Espases University Hospital
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 Paricalcitol and Epoetin beta in people with Anemia, run by Hospital Son Espases at 1 site in Spain.
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 12 inclusion and 8 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 9 Dec 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Difficult inclusion of patients diagnosed with renal anemia in chronic hemodialysis patients without hyperparathyroidism.). 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?
Changes in ESA dosage (time frame: 6 months). 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 NCT02876211, which also lists 3 linked publications.
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 9 Dec 2024.