AnemiaPhase 4NCT01768351
Paricalcitol Effect on Anemia in CKD
A Phase 4 study testing Paricalcitol and Calcitriol in people with Anemia and Chronic Kidney Disease, run by Federico II University at 1 site in Italy.
Trial summary
Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Chronic Kidney Disease
- What is being tested?
- Paricalcitol and Calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Oct 2012
- 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
- written informed consent
- CKD stage 3-5 (eGFR <60 ml/min/1,73 m2)
- PTH 30-300 pg/ml
- Hb <10 g/dl >3 consecutive months
- Ferritin > 100 ng/ml
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- transferrin saturation (TSAT) 20-40%
- mean corpuscular volume (MCV) 85-95%
- for patients treated with Ace-inhibitors or angiotensin receptor blockers, dose stable >3 months
- for patients treated with erythropoiesis-stimulating agents (ESA), dose stable >3 months
Who cannot join
- anemia due to non renal cause
- presence of malignancies, inflammatory or infectious disease >3 months
- pregnancy
- bleeding >6 months
- C-reactive protein (CRP) >1 mg/dl
- poorly controlled hypertension (PAS > 170 mmHG and PAD >100 mmHg)
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- severe malnutrition
- hypercalcemia (>10,5 mg/dl)
- hyperphosphatemia (>5,5 mg/dl)
- surgical interventions >3 months
- acute myocardial infarction, unstable angina, stroke or transitory ischemic attack, deep venous or pulmonary thromboembolism, congestive heart failure >3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease
Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the benefits are greater with the newer vitamin D analog paricalcitol when compared with calcitriol. A large gap exists in our knowledge between epidemiological studies in human that demonstrate improved outcomes with vitamin D use and observations in preclinical studies demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.
Read the detailed description
To better understand the direct effects of paricalcitol on anemia in patients with chronic kidney disease (stage 3-5), we conducted a pilot trial in 60 patients who were randomly allocated equally to 2 groups to receive or not paricalcitol orally for 6 months.
- Conditions
- Anemia, Chronic Kidney Disease
- Being tested
- Paricalcitol, Calcitriol
- Keywords
- anemia, chronic kidney disease, vitamin D, paricalcitol, hyperparathyroidism
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Hyperparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Also called Zemplar
Zemplar cp 1 mcg/day per os
CalcitriolDrug
Also called Rocaltrol
Rocaltrol cp 0,5 mcg every other day per os
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients receiving treatment for secondary hyperparathyroidism with calcitriol. The calcitriol dosage schedule provided for an initial dose of 0.5 mch every other day and titration was performed on the basis of the serum levels of intact PTH (iPTH) (target 150-300 pg/mL), Ca, P and Ca x P product as suggested by the US National Kidney Foundation Dialysis outcomes Quality Initiative (NKF-DOQI) and Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Receives: Drug: Calcitriol |
| Paricalcitol | Experimental | Patients treated by Paricalcitol for hyperparathyroidism. The paricalcitol initial dose was 1 mcg/die, and titration was performed on the basis of the serum levels of iPTH, Ca, P and Ca x P product as suggested by the NKF-DOQI and KDIGO guidelines. Receives: Drug: Paricalcitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modification in hemoglobin levels
Measured: 6 months
Secondary outcomes (1)
Modifications in urinary protein excretion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionOct 2012
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.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleonora Riccio, Federico II University
- Investigators
- Eleonora Riccio, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768351
- Sponsor's protocol ID
- PCX1234
- Other IDs
- paranemia
- Status last verified
- Nov 2012
- First submitted
- 13 Jan 2013
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Riccio E, Sabbatini M, Bruzzese D, Capuano I, Migliaccio S, Andreucci M, Pisani A. Effect of paricalcitol vs calcitriol on hemoglobin levels in chronic kidney disease patients: a randomized trial. PLoS One. 2015 Mar 17;10(3):e0118174. doi: 10.1371/journal.pone.0118174. eCollection 2015.
PubMed 25781618
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Effect of Paricalcitol on Anemia in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01768351
- Acronym / sponsor ID
- PCX1234
- Conditions
- Anemia, Chronic Kidney Disease
- Keywords
- anemia, chronic kidney disease, vitamin D, paricalcitol, hyperparathyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Jan 2013 (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.
Current activated Vitamin D therapies are approved for treating secondary hyperparathyroidism in chronic kidney disease (CKD), and a large body of experimental data in animals confirms the effects of Vitamin D that extend beyond mineral metabolism. Several studies show that the benefits are greater with the newer vitamin D analog paricalcitol when compared with calcitriol. A large gap exists in our knowledge between epidemiological studies in human that demonstrate improved outcomes with vitamin D use and observations in preclinical studies demonstrating the pleiotropic effects of Vitamin D. To explore the provenance of epidemiological outcomes in CKD, we conducted a pilot randomized trial to determine whether the use of paricalcitol, compared to calcitriol, leads to improvement in anemia, a marker associated with worse outcomes in chronic kidney disease, and whether this effect not only reflects the hyperparathyroidism correction, but is also dependent on the direct effects of paricalcitol on erythroid progenitor cells.
Detailed description
To better understand the direct effects of paricalcitol on anemia in patients with chronic kidney disease (stage 3-5), we conducted a pilot trial in 60 patients who were randomly allocated equally to 2 groups to receive or not paricalcitol orally for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: CalcitriolPatients receiving treatment for secondary hyperparathyroidism with calcitriol. The calcitriol dosage schedule provided for an initial dose of 0.5 mch every other day and titration was performed on the basis of the serum levels of intact PTH (iPTH) (target 150-300 pg/mL), Ca, P and Ca x P product as suggested by the US National Kidney Foundation Dialysis outcomes Quality Initiative (NKF-DOQI) and Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. |
| Paricalcitol | Experimental | Drug: ParicalcitolPatients treated by Paricalcitol for hyperparathyroidism. The paricalcitol initial dose was 1 mcg/die, and titration was performed on the basis of the serum levels of iPTH, Ca, P and Ca x P product as suggested by the NKF-DOQI and KDIGO guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age > 18
- written informed consent
- CKD stage 3-5 (eGFR <60 ml/min/1,73 m2)
- PTH 30-300 pg/ml
- Hb <10 g/dl >3 consecutive months
Key exclusion criteria (11 listed)
- anemia due to non renal cause
- presence of malignancies, inflammatory or infectious disease >3 months
- pregnancy
- bleeding >6 months
- C-reactive protein (CRP) >1 mg/dl
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: ZemplarZemplar cp 1 mcg/day per os | Drug | Paricalcitol |
| CalcitriolAlso: RocaltrolRocaltrol cp 0,5 mcg every other day per os | Drug | Control |
Primary outcome
Modification in hemoglobin levels
Time frame: 6 months
1 secondary outcome
Modifications in urinary protein excretion
Time frame: 6 months
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 30 Jul 2014.
- Derived from this study: PubMed 25781618Riccio E, Sabbatini M, Bruzzese D, Capuano I, Migliaccio S, Andreucci M, Pisani A. Effect of paricalcitol vs calcitriol on hemoglobin levels in chronic kidney disease patients: a randomized trial. PLoS One. 2015 Mar 17;10(3):e0118174. doi: 10.1371/journal.pone.0118174. eCollection 2015.
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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.
Eleonora Riccio, MD principal investigator
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 Calcitriol in people with Anemia and Chronic Kidney Disease, run by Federico II University at 1 site in Italy.
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 10 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: finished, as of the sponsor's last update on 30 Jul 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 Italy. 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.
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 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?
Modification in hemoglobin levels (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 NCT01768351, 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 30 Jul 2014.