Secondary Hyperparathyroidism Due to Renal CausesPhase 4PARIDOINALNCT01939977
Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation.
A Phase 4 study testing Paricalcitol and Calcifediol in people with Secondary Hyperparathyroidism Due to Renal Causes, run by Fundación Senefro at 16 sites in Spain.
Trial summary
To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism Due to Renal Causes
- What is being tested?
- Paricalcitol and Calcifediol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 16 sitesSpain
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient that have willingly signed and dated the ICD (Informed Consent Document) approved by the EC (Ethics Committee) before any study procedure and after they have been explained the study, they have read the ICD and have had the opportunity to make questions about it.
- Patients of both genders and older than 18 years candidates to an immediately renal transplantation from living or deceased donor.
- 24 hours previous to the transplantation, patient must have a significant grade of secondary hyperparathyroidism, defined as iPTH (Intact parathyroid hormone) levels between 110 and 600 pg/mL as per central laboratory results.
- Patients with a preformed antibody panel <20% 24 hours before the transplantation or that are considered by the investigator of low immunological risk (PRA determination is being done on local laboratory, not central).
- Serum calcium (corrected by albumin) < 10 mg/dL 24 hour previous to the transplantation as per central laboratory results.
- Patients that are to be treated with immunosuppression based on tacrolimus, mofetil mycofenolate or mycophenolic acid and with steroids and that are not going to be treated with mTOR (mammalian target of rapamycin) inhibitors. Tacrolimus and steroids must not be removed on the 6 month post-transplantation.
- Patients that are able to take oral capsules on the first week post-transplantation.
Who cannot join
- Third or subsequent renal transplantation.
- Positive cross-match assay or ABO (A-B-0) incompatibility
- Patients that have been or are going to be recipients of other organs other than the kidney or a double kidney transplantation.
- Patients with history of allergic reaction or sensibility to paricalcitol, calcifediol or similar study drugs (related with vitamin D).
- Patients with chronic gastrointestinal disease, that, based on investigators criteria, can cause significant gastrointestinal malabsorption.
- Patient with hypo or hyperthyroidism not controlled based on investigators criteria.
Show all 14Show fewer
- Patient with uncontrolled hypertension based on investigators criteria.
- Patients that, 48 hours previous to transplantation, have been receiving calcimimetics.
- Patients with VIH (human immunodeficiency virus)infection of positive serology for HBV (hepatitis B virus) and/or HCV (hepatitis C virus)
- Patients on treatment with drugs contraindicated with paricalcitol and calcifediol (based on SMPC)
- Patients that are participating on other clinical trial with investigational drugs.
- Women of childbearing potential (defined as those whose last menstruation was <2 years ago and that are not surgically sterilized) that are not willing to use correct contraception during study treatment.
- Patient with other diseases or conditions that based on investigators criteria are not suitable for the study.
- Treatment will not be started if the Calcium-Phosphorus product (CAxP)is >55 mg2/dL2 or in case of hyperphosphatemia considered significant as per investigator criteria
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Spain16 sites
Complexo Hospitalario Universitario A Coruna
A Coruña, 15006
Hospital Universitari Germans Trias I Pujol de Badalona
Badalona, Barcelona, 08916
Hospital Del Mar
Barcelona, 08003
Fundació Puigvert-Iuna
Barcelona, 08025
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Hospital Puerta Del Mar
Cadiz, 11009
Hospital Reina Sofía
Córdoba, 14004
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Complejo Hospitalario Universitario de Canarias
Las Palmas de Gran Canaria, 38320
Hospital Ramón Y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Complejo Hospitalario Regional de Málaga
Málaga, 29010
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Virgen Del Rocío
Seville, 41013
Hospital Universitari I Politècnic La Fe
Valencia, 46026
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.
To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
Read the detailed description
The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
- Being tested
- Paricalcitol, Calcifediol
- Keywords
- Hyperparathyroidism, Hyperparathyroidism Secondary, Paricalcitol, Calcifediol, Parathyroid hormone, Renal transplantation
- Medical subject headings
- Hyperparathyroidism, Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Also called Zemplar
1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours.
CalcifediolDrug
Also called Hidroferol
5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Experimental | Paricalcitol oral capsules. Receives: Drug: Paricalcitol |
| Calcifediol | Active comparator | Calcifediol oral drops. Receives: Drug: Calcifediol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With iPTH Serum Concentration >110 pg/mL.
Percentage of patients with iPTH serum concentration >110 pg/mL 6 month after transplant.
Measured: 6 months
Secondary outcomes (15)
Change on iPTH Serum Concentration. Intention to Treat Analysis.
Change on iPTH serum concentration on each treatment group 6 month post transplantation.
Measured: 6 months
Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.
Measured: 6 months
Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.
Measured: 6 month
Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.
Measured: 6 months
Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage.
Patients with at least one of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage.
Measured: 6 months
Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.
Measured: 6 months
Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.
Measured: 6 months
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.
Measured: Months 1, 3 and 6
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.
Measured: Months 1, 3 and 6
Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation.
Baseline speed of pulse wave was performed between 1 week and 1 month post transplant; next measure of speed of pulse wave performed at month 6 post transplant.
Measured: 6 months.
Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation.
Percentage of patients with hypercalcemia (defined as serum calcium levels > 10,3 mg/dl) on each treatment group at 6 months post transplantation.
Measured: 6 months
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation.
HLAs corresponding to MHC (major histocompatibility complex) class I (A, B, and C) present peptides from inside the cell. HLAs corresponding to MHC class II (DP, DM, DO, DQ, and DR) present antigens from outside of the cell to T-lymphocytes.
Measured: 6 months
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.
Measured: 6 months
Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.
Measured: 6 months
Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group
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 posted11 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Secondary Hyperparathyroidism Due to Renal CausesStudies 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
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Senefro
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie, Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
- Investigators
- Josep M Cruzado, Dr, Principal investigator, Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939977
- Sponsor's protocol ID
- ACA-SPAI-11-24
- Other IDs
- 2013-001326-25
- Acronym
- PARIDOINAL
- Status last verified
- May 2018
- First submitted
- 28 Aug 2013
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.
- ClinicalTrials.gov ID
- NCT01939977
- Acronym / sponsor ID
- PARIDOINAL / ACA-SPAI-11-24
- Keywords
- Hyperparathyroidism, Hyperparathyroidism Secondary, Paricalcitol, Calcifediol, Parathyroid hormone, Renal transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Fundación SenefroUniversity, hospital or other
- Collaborators
- AbbVie, Effice Servicios Para la Investigacion S.L.
- Study start
- Jan 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Posted 19 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
Detailed description
The purpose of this study is to demonstrate the superiority of paricalcitol treatment at early renal post-transplantation (M6) in the control of iPTH (Intact parathyroid hormone) compared to the use of vitamin D nutritional supplements (calcifediol) in patients with renal transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol | Experimental | Drug: ParicalcitolParicalcitol oral capsules. |
| Calcifediol | Active comparator | Drug: CalcifediolCalcifediol oral drops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient that have willingly signed and dated the ICD (Informed Consent Document) approved by the EC (Ethics Committee) before any study procedure and after they have been explained the study, they have read the ICD and have had the opportunity to make questions about it.
- Patients of both genders and older than 18 years candidates to an immediately renal transplantation from living or deceased donor.
- 24 hours previous to the transplantation, patient must have a significant grade of secondary hyperparathyroidism, defined as iPTH (Intact parathyroid hormone) levels between 110 and 600 pg/mL as per central laboratory results.
- Patients with a preformed antibody panel <20% 24 hours before the transplantation or that are considered by the investigator of low immunological risk (PRA determination is being done on local laboratory, not central).
- Serum calcium (corrected by albumin) < 10 mg/dL 24 hour previous to the transplantation as per central laboratory results.
Key exclusion criteria (14 listed)
- Third or subsequent renal transplantation.
- Positive cross-match assay or ABO (A-B-0) incompatibility
- Patients that have been or are going to be recipients of other organs other than the kidney or a double kidney transplantation.
- Patients with history of allergic reaction or sensibility to paricalcitol, calcifediol or similar study drugs (related with vitamin D).
- Patients with chronic gastrointestinal disease, that, based on investigators criteria, can cause significant gastrointestinal malabsorption.
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: Zemplar1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours. | Drug | Paricalcitol |
| CalcifediolAlso: Hidroferol5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment. | Drug | Calcifediol |
Primary outcome
Percentage of Patients With iPTH Serum Concentration >110 pg/mL.
Time frame: 6 months
Percentage of patients with iPTH serum concentration >110 pg/mL 6 month after transplant.
15 secondary outcomes
Change on iPTH Serum Concentration. Intention to Treat Analysis.
Time frame: 6 months
Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study.
Time frame: 6 months
Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT.
Time frame: 6 month
Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group.
Time frame: 6 months
Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage.
Time frame: 6 months
Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group.
Time frame: 6 months
Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group.
Time frame: 6 months
Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation.
Time frame: Months 1, 3 and 6
Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation.
Time frame: Months 1, 3 and 6
Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation.
Time frame: 6 months.
Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation.
Time frame: 6 months
Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation.
Time frame: 6 months
Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group.
Time frame: 6 months
Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group.
Time frame: 6 months
Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Josep M Cruzado, Dr principal investigator
Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.
16 sites 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 Calcifediol in people with Secondary Hyperparathyroidism Due to Renal Causes, run by Fundación Senefro at 16 sites 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 7 inclusion and 14 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients With iPTH Serum Concentration >110 pg/mL. (time frame: 6 months). 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 19 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.