Chronic Kidney Disease, UnspecifiedPhase 4PALIFENCT01820078
Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)
A Phase 4 study testing Experimental arm and Comparator Arm in people with Chronic Kidney Disease, Unspecified, run by Fundación Renal Iñigo Alvarez De Toledo at 25 sites in Spain.
Trial summary
The purpose of this study is to estimate the differences between albuminuria values determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last observation caused by paricalcitol between the group of control and group of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Unspecified
- What is being tested?
- Experimental arm and Comparator Arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 25 sitesSpain
- Study dates
- May 2012to Dec 2013
- 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
- Informed consent signed
- Patients will be men or women, between 18 and 75 years old.
- Patients must have been taken an stable dosis of Angiotensine Converter Enzyme Inhibitor, Angiotensine Receptor Antagonism or antialdosterone at last 6 months before screening visit.
- Patients should not be on dialysis treatment.
- Women should not be pregnant, or in fertile period (at last 1 year postmenopausal or chirurgic sterilized or using this contraceptive methods: condoms, gel, intrauterine devices, anticonceptives, etc. During at last 3 months after the study beginning.
Who cannot join
- Patients have taken active vitamin D during 6 months after the screening.
- Patients with allergy o sensibility to paricalcitol.
- Patients with acute CKD 12 weeks before the screening.
- Patients with chronical gastrointestinal disease.
- Patients with hypo or hyperthyroidism.
- Patients with secondary hypertension
Show all 17Show fewer
- Bad controled hypertension patients
- Patients with renal lithiasis
- Patients with drug dependence
- Patients taking calcitonins, biphosphonates, cinacalcet or others Ca-metabolism drugs.
- Patients taking immunosuppressor drugs.
- Patients not adequate to study as medical opinion.
- HIV patients
- Seric P > 5.0 mg/dl.
- Seric Ca> 10,0 mg/dl.
- Proteinuria > 3.500 mg/g
- Hypoalbuminemia < 3g/dl
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Hosp. U. Fundación de Alcorcón
Alcorcón, Madrid, 28922
Hospital Universitario General de Alicante
Alicante, Alicante, 03010
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08035
Fundació Puigvert
Barcelona, Barcelona, 08025
Hospital Valle de Hebrón
Barcelona, Barcelona, 08035
Hospital de Galdakao
Bilbao, Basque Country, 48960
Hospital Comarcal Da Costa
Burela de Cabo, Lugo, 27880
Hospital Reina Sofía
Córdoba, Córdoba, 14004
Hospital Virgen de las Nieves
Granada, Granada, 18014
Hospital Gregorio Marañon
Madrid, Madrid, 28007
Hospital Ramon y Cajal
Madrid, Madrid, 28034
Clínico San Carlos
Madrid, Madrid, 28040
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital 12 de Octubre
Madrid, Madrid, 28046
Hospital Universitario La Paz
Madrid, Madrid, 28046
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Carlos Haya
Málaga, Málaga, 29010
Hospital Son Espases
Mallorca, Balearic Islands, 07010
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
Hospital Virgen de la Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010
Hospital Universitario Virgen de la Macarena
Seville, Sevilla, 41009
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Hospital Dr Peset
Valencia, Valencia, 46017
Hospital Clinico Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
Official title: Effect of Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study): a Randomized Study
The purpose of this study is to estimate the differences between albuminuria values determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last observation caused by paricalcitol between the group of control and group of treatment.
Read the detailed description
Clinical Trial to estimate UACR determined albuminuria differences between treatment and non-treatment groups from basal intake to last study-related observation. Patients should suffer proteinuric Chronical Kidney Disease and recovered levels of seric 25(OH)D. Also, this clinical trial tries to determinate the effect of paricalcitol over several metabolic and inflammatory parameters on patients.
- Conditions
- Chronic Kidney Disease, Unspecified
- Being tested
- Experimental arm, Comparator Arm
- Keywords
- Chronic, Kidney, Disease, Proteinuria, Albuminuria, Paricalcitol
- Medical subject headings
- Renal Insufficiency, Chronic, Bronchiolitis Obliterans Syndrome, Disease, Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental armDrug
Also called Treatment
Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)
Comparator ArmOther
Also called Daily treatment for CKD
Daily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc.
| Study group | Role | What they receive |
|---|---|---|
| Paricalcitol, Daily treatment, CKD | Experimental | Experimental Arm Receives: Drug: Experimental arm; Other: Comparator Arm |
| Daily treatment for CKD | Other | Comparator Arm Receives: Other: Comparator Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Albuminuria in proteinuric Chronical Kidney Disease patients
Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit.
Measured: 1 year
Secondary outcomes (1)
Change from baseline albuminuria at 6 months
Determinate % of patients with an over 20% of albuminuria descent from baseline
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 posted28 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionSep 2013
- Study completionDec 2013 (estimated)
Why it stopped: Recruitment not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease, UnspecifiedStudies 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
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Renal Iñigo Alvarez De Toledo
- Sponsor type
- University, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Responsible party
- Sponsor
- Investigators
- Jesús Egido de los Ríos, MD, Principal investigator, Fundación Renal Iñigo Alvarez De Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820078
- Sponsor's protocol ID
- PALIFE-2011-01
- Acronym
- PALIFE
- Status last verified
- Nov 2013
- First submitted
- 30 Jul 2012
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study): a Randomized Study
- ClinicalTrials.gov ID
- NCT01820078
- Acronym / sponsor ID
- PALIFE / PALIFE-2011-01
- Conditions
- Chronic Kidney Disease, Unspecified
- Keywords
- Chronic, Kidney, Disease, Proteinuria, Albuminuria, Paricalcitol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment not reached
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Fundación Renal Iñigo Alvarez De ToledoUniversity, hospital or other
- Collaborators
- Effice Servicios Para la Investigacion S.L.
- Study start
- May 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 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.
The purpose of this study is to estimate the differences between albuminuria values determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last observation caused by paricalcitol between the group of control and group of treatment.
Detailed description
Clinical Trial to estimate UACR determined albuminuria differences between treatment and non-treatment groups from basal intake to last study-related observation. Patients should suffer proteinuric Chronical Kidney Disease and recovered levels of seric 25(OH)D. Also, this clinical trial tries to determinate the effect of paricalcitol over several metabolic and inflammatory parameters on patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paricalcitol, Daily treatment, CKD | Experimental | Drug: Experimental arm, Other: Comparator ArmExperimental Arm |
| Daily treatment for CKD | Other | Other: Comparator ArmComparator Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent signed
- Patients will be men or women, between 18 and 75 years old.
- Patients must have been taken an stable dosis of Angiotensine Converter Enzyme Inhibitor, Angiotensine Receptor Antagonism or antialdosterone at last 6 months before screening visit.
- Patients should not be on dialysis treatment.
- Women should not be pregnant, or in fertile period (at last 1 year postmenopausal or chirurgic sterilized or using this contraceptive methods: condoms, gel, intrauterine devices, anticonceptives, etc. During at last 3 months after the study beginning.
Key exclusion criteria (17 listed)
- Patients have taken active vitamin D during 6 months after the screening.
- Patients with allergy o sensibility to paricalcitol.
- Patients with acute CKD 12 weeks before the screening.
- Patients with chronical gastrointestinal disease.
- Patients with hypo or hyperthyroidism.
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 |
|---|---|---|
| Experimental armAlso: TreatmentOral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study) | Drug | Paricalcitol, Daily treatment, CKD |
| Comparator ArmAlso: Daily treatment for CKDDaily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc. | Other | Daily treatment for CKD, Paricalcitol, Daily treatment, CKD |
Primary outcome
Albuminuria in proteinuric Chronical Kidney Disease patients
Time frame: 1 year
Estimate differences between groups based on albuminuric level determined as UACR from basal to last observation visit.
1 secondary outcome
Change from baseline albuminuria at 6 months
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Jesús Egido de los Ríos, MD principal investigator
Fundación Renal Iñigo Alvarez De Toledo
25 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 Experimental arm and Comparator Arm in people with Chronic Kidney Disease, Unspecified, run by Fundación Renal Iñigo Alvarez De Toledo at 25 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 5 inclusion and 17 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 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
The study was stopped early (reason given: Recruitment not reached). 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?
Albuminuria in proteinuric Chronical Kidney Disease patients (time frame: 1 year). 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 28 Nov 2013.