Chronic Kidney DiseasePhase 3SENPARICNCT01820767
Paricalcitol Over Inflammatory Parameters on Chronical Kidney Disease Patients
A Phase 3 study testing Paricalcitol, Paricalcitol, atorvastatin and Atorvastatin in people with Chronic Kidney Disease, run by Ricardo Mouzo Mirco at 2 sites in Spain.
Trial summary
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Paricalcitol, Paricalcitol, atorvastatin and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesSpain
- Study dates
- Aug 2012to Mar 2014
- Phase
- Phase 3
- 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
- Vd CKD patients using haemodialysis during 3 or more months.
- Tunnelized-bearer permanent catheters on haemodialysis at last 6 months previous at the beginning of the study. .
- Kt stable, over 45 litres on both sexs.
- Patients in treatment wiht atorvastatin
- Patients without infectious or inflammatory processes over 8 weeks.
- Two consecutive PTH < than 400 pg/ml; Ca<10.2 and P <7.0 mg/dl.
Who cannot join
- Patients > 18 years.
- Pregnant women.
- Patients hospitalized 4 weeks before the beginning of the treatment.
- Immunosuppressor intake.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de León
León, 24008
Hospital El Bierzo. Servicio de Nefrología.
Ponferrada, (León)., 24411,
About this study
Official title: Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.
Read the detailed description
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. This study uses paricalcitol (vitamin D) versus atorvastatin versus paricalcitol plus atorvastatin treatments.
- Conditions
- Chronic Kidney Disease
- Being tested
- Paricalcitol, Paricalcitol, atorvastatin, Atorvastatin
- Keywords
- Chronic Kidney Disease, Vd-stadium., Inflammatory patterns, Paricalcitol, Atorvastatin
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParicalcitolDrug
Also called Group 1
Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.
Paricalcitol, atorvastatinDrug
Also called G2
Oral Paricalcitol. parathyroid hormone i mgc/100. 3 days a week, the same day as haemodialysis, during 12 weeks.
Atorvastatin: 20 mg/day oral (1 take) during 12 weeks.
AtorvastatinDrug
Also called G3
Atorvastatin: 20 mg/day oral (1 take) during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol | Experimental | SUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week. Receives: Drug: Paricalcitol |
| Paricalcitol, Atorvastatin | Active comparator | SUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg) Receives: Drug: Paricalcitol, atorvastatin |
| Atorvastatin | Active comparator | SUBGROUP 3 (G3): Atorvastatin (same G2 dosis) Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment
Measure parameter: IL-2
Measured: 12 weeks of treatment wiht visits and analysis
Oxidative stress and inflammative parameters
Measure unit: IL-4
Measured: 12 weeks of treatment
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
IL-5
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
IL-6
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
IL-10
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
IL-13
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
TNF-beta
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
CD3
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
CD4
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
CD8
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
CD19
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
CD25
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
CD56
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
CD69
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
CD95
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
COX-2
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
iNOS
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
PGE2
Measured: 12 weeks of treatment with visits and analysis
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
FGF-23
Measured: 12 weeks of treatment with visits and analysis
Secondary outcomes (15)
Nutritional Parameters
Weight
Measured: 12 weeks of treatment with visits and analysis
Erythropoietin requirements variations
Fe
Measured: 12 weeks of treatment with visits and analysis
Assess potential benefits inflammatory markers
PTHi
Measured: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Height
Measured: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Body Mass Index (BMI)
Measured: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Abdominal circumference
Measured: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Triceps skin fold circumference
Measured: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Bioimpedance
Measured: 12 weeks of treatment with visits and analysis
Anaemia parameters
Hemogram
Measured: 12 weeks of treatment
Anaemia Parameters
Biochemistry
Measured: 12 weeks of treatment
Erythropoietin requirement variations
Ferritin
Measured: 12 weeks of treatment with visits and analysis
Erythropoietin requirement variations
Transferrin saturation index
Measured: 12 weeks of treatment with visits and analysis
Erythropoietin requirements variations
B12
Measured: 12 weeks of treatment with visits and analysis
Erythropoietin requirements variations
Folic Acid
Measured: 12 weeks of treatment with visits and analysis
Assess potential benefits in inflammatory markers
Kt
Measured: 16 weeks, the complete duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startAug 2012
- Primary completionOct 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ricardo Mouzo Mirco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ricardo Mouzo Mirco, Hospital El Bierzo
- Investigators
- Ricardo Mouzo Mirco, MD, Principal investigator, Hospital El Bierzo, Fuentesnuevas Ponferrada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820767
- Sponsor's protocol ID
- SENPARIC-2011-01
- Acronym
- SENPARIC
- Status last verified
- Aug 2018
- First submitted
- 19 Mar 2013
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paricalcitol Action on Parameters of Inflammation and Oxidative Stress in Patients With Chronic Kidney Disease Stage Vd Carriers Tunneled Hemodialysis Catheters
- ClinicalTrials.gov ID
- NCT01820767
- Acronym / sponsor ID
- SENPARIC / SENPARIC-2011-01
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Vd-stadium., Inflammatory patterns, Paricalcitol, Atorvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ricardo Mouzo MircoUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Mar 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.
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients, over the effect of inflammatory and oxidative stress parameters.
Detailed description
Use of Paricalcitol in stage Vd Chronic Kidney Disease patients using a permanent catheter due to haemodialysis; over the effect of inflammatory and oxidative stress parameters. This study uses paricalcitol (vitamin D) versus atorvastatin versus paricalcitol plus atorvastatin treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol | Experimental | Drug: ParicalcitolSUBGROUP 1 (G1): Paricalcitol oral dosis triphosphoinositide mgc/100, 3 days a week. |
| Paricalcitol, Atorvastatin | Active comparator | Drug: Paricalcitol, atorvastatinSUBGROUP 2 (G2): Paricalcitol (same dosis than G1) + Atorvastatin (1 daily dosis 20 mg) |
| Atorvastatin | Active comparator | Drug: AtorvastatinSUBGROUP 3 (G3): Atorvastatin (same G2 dosis) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Vd CKD patients using haemodialysis during 3 or more months.
- Tunnelized-bearer permanent catheters on haemodialysis at last 6 months previous at the beginning of the study. .
- Kt stable, over 45 litres on both sexs.
- Patients in treatment wiht atorvastatin
- Patients without infectious or inflammatory processes over 8 weeks.
Key exclusion criteria (4 listed)
- Patients > 18 years.
- Pregnant women.
- Patients hospitalized 4 weeks before the beginning of the treatment.
- Immunosuppressor intake.
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: Group 1Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks. | Drug | Paricalcitol |
| Paricalcitol, atorvastatinAlso: G2Oral Paricalcitol. parathyroid hormone i mgc/100. 3 days a week, the same day as haemodialysis, during 12 weeks. Atorvastatin: 20 mg/day oral (1 take) during 12 weeks. | Drug | Paricalcitol, Atorvastatin |
| AtorvastatinAlso: G3Atorvastatin: 20 mg/day oral (1 take) during 12 weeks | Drug | Atorvastatin |
Primary outcome
Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment wiht visits and analysis
Measure parameter: IL-2
Oxidative stress and inflammative parameters
Time frame: 12 weeks of treatment
Measure unit: IL-4
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
IL-5
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
IL-6
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
IL-10
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
IL-13
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
TNF-beta
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
CD3
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
CD4
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
CD8
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
CD19
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
CD25
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
CD56
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
CD69
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
CD95
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
COX-2
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
iNOS
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
PGE2
Oxidative stress and inflammative parameters in patients with CKD stage vitamin D after 12 weeks of treatment
Time frame: 12 weeks of treatment with visits and analysis
FGF-23
15 secondary outcomes
Nutritional Parameters
Time frame: 12 weeks of treatment with visits and analysis
Erythropoietin requirements variations
Time frame: 12 weeks of treatment with visits and analysis
Assess potential benefits inflammatory markers
Time frame: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Time frame: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Time frame: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Time frame: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Time frame: 12 weeks of treatment with visits and analysis
Nutritional Parameters
Time frame: 12 weeks of treatment with visits and analysis
Anaemia parameters
Time frame: 12 weeks of treatment
Anaemia Parameters
Time frame: 12 weeks of treatment
Erythropoietin requirement variations
Time frame: 12 weeks of treatment with visits and analysis
Erythropoietin requirement variations
Time frame: 12 weeks of treatment with visits and analysis
Erythropoietin requirements variations
Time frame: 12 weeks of treatment with visits and analysis
Erythropoietin requirements variations
Time frame: 12 weeks of treatment with visits and analysis
Assess potential benefits in inflammatory markers
Time frame: 16 weeks, the complete duration of the study
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 24 Aug 2018.
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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.
Ricardo Mouzo Mirco, MD principal investigator
Hospital El Bierzo, Fuentesnuevas Ponferrada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paricalcitol, Paricalcitol, atorvastatin and Atorvastatin in people with Chronic Kidney Disease, run by Ricardo Mouzo Mirco at 2 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 6 inclusion and 4 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Oxidative stress and inflammative parameters in patients wiht CKD stage Vitamin D after 12 weeks of treatment (time frame: 12 weeks of treatment wiht visits and analysis). The study lists 19 primary outcomes in all. 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 24 Aug 2018.