Kidney Failure, ChronicPhase 4NEFROVID2010NCT01442272
Value Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
A Phase 4 study testing Hidroferol®, Paricalcitol: Zemplar® and Habitual medication in people with Kidney Failure, Chronic and Disorder of Vitamin D, run by Hospital Universitario de Canarias at 2 sites in Spain.
Trial summary
The purpose of this study is to determine the value the additional antiproteinuric effects of vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with lack of vitamin D and residual proteinuria higher 0,5 grams/day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Disorder of Vitamin D
- What is being tested?
- Hidroferol®, Paricalcitol: Zemplar® and Habitual medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2012to Oct 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
- Male/female Patients older 18 years old
- Patients have signed written informed consent
- Chronic Kidney Illness phase II-IV plus residual proteinuria >0,5 grams/day (two or more consecutive occasions) and plus beta blockers treatment from AARS during al least 3 months.
- Serum levels of calcifediol in the lack of level (15-30 ng/ml).
Who cannot join
- Bad control of high blood pressure (higher or same 180/110 mmHg)
- Bad control of diabetes (HbA1c higher 9,5 in the last three months period)
- Hypercalcemia (<10,2 mg/dL) o hyperphosphatemia(>5,5 mg/dL), CaxPO4>50, hypercalciuria (urin Ca/Cr quotient > 0,15)
- Vitamin D treatment or any analogous
- Hepatic failure ( AST o ALT > 3 times higher than normal limit)
- medical history of poor nutrient intestinal absorptions or chronic diarrhea
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- Active nephrolithiasis
- Treatment with medication wich can change vitamin D metabolism (phenobarbital, phenytoin, rifampicin)
- Participation in other Clinic Trial in 3 last months
- Active Alcoholism
- Neoplasia precedent (except cutaneous no melanoma)
- Pregnant women or while breastfeeding
- Vitamin D hypersensitivity or any its excipient hypersensitivity
- Any other condition from Research
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, S/C Tenerife, 38320
Ana Aldea, +34922678115, a.aldea@gmail.com
Victor Lorenzo
- Recruiting
HUC
San Cristóbal de La Laguna, S/c Tenerife, 38320
ANA ALDEA, +34922678115, a.aldea@gmail.com
Victor Lorenzo
About this study
Official title: Clinical Trial, Open, Parallel Groups , Value the Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
The purpose of this study is to determine the value the additional antiproteinuric effects of vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with lack of vitamin D and residual proteinuria higher 0,5 grams/day.
- Conditions
- Kidney Failure, Chronic, Disorder of Vitamin D
- Being tested
- Hidroferol®, Paricalcitol: Zemplar®, Habitual medication
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hidroferol®Drug
Also called B
Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months
Paricalcitol: Zemplar®Drug
Also called C
Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months
Habitual medicationDrug
Also called A
Habitual medication
| Study group | Role | What they receive |
|---|---|---|
| Habitual medication withuot additional | No intervention | Not described Receives: Drug: Habitual medication |
| Habitual medication plus Hidroferol® | Active comparator | Not described Receives: Drug: Hidroferol® |
| Habitual medication plus Zemplar® | Active comparator | Not described Receives: Drug: Paricalcitol: Zemplar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning.
Measured: 1-3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2012 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442272
- Sponsor's protocol ID
- NEFROVID2010
- Acronym
- NEFROVID2010
- Status last verified
- Sep 2011
- First submitted
- 26 Sep 2011
- Last updated
- 21 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial, Open, Parallel Groups , Value the Antiproteinuric Effects From Vitamin D Derivatives in Patient With Chronic Kidney Illness and the Lack of Vitamin D
- ClinicalTrials.gov ID
- NCT01442272
- Acronym / sponsor ID
- NEFROVID2010 / NEFROVID2010
- Conditions
- Kidney Failure, Chronic, Disorder of Vitamin D
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 28 Sep 2011 (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 determine the value the additional antiproteinuric effects of vitamin D derivatives treatment, in patients with Chronic Kidney Illness phase II-IV, with lack of vitamin D and residual proteinuria higher 0,5 grams/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Habitual medication withuot additional | No intervention | Drug: Habitual medication |
| Habitual medication plus Hidroferol® | Active comparator | Drug: Hidroferol® |
| Habitual medication plus Zemplar® | Active comparator | Drug: Paricalcitol: Zemplar® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male/female Patients older 18 years old
- Patients have signed written informed consent
- Chronic Kidney Illness phase II-IV plus residual proteinuria >0,5 grams/day (two or more consecutive occasions) and plus beta blockers treatment from AARS during al least 3 months.
- Serum levels of calcifediol in the lack of level (15-30 ng/ml).
Key exclusion criteria (14 listed)
- Bad control of high blood pressure (higher or same 180/110 mmHg)
- Bad control of diabetes (HbA1c higher 9,5 in the last three months period)
- Hypercalcemia (<10,2 mg/dL) o hyperphosphatemia(>5,5 mg/dL), CaxPO4>50, hypercalciuria (urin Ca/Cr quotient > 0,15)
- Vitamin D treatment or any analogous
- Hepatic failure ( AST o ALT > 3 times higher than normal limit)
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 |
|---|---|---|
| Hidroferol®Also: BHidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months | Drug | Habitual medication plus Hidroferol® |
| Paricalcitol: Zemplar®Also: CParicalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months | Drug | Habitual medication plus Zemplar® |
| Habitual medicationAlso: AHabitual medication | Drug | Habitual medication withuot additional |
Primary outcome
Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning.
Time frame: 1-3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
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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.
2 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 Hidroferol®, Paricalcitol: Zemplar® and Habitual medication in people with Kidney Failure, Chronic and Disorder of Vitamin D, run by Hospital Universitario de Canarias 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 4 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: status not confirmed, as of the sponsor's last update on 21 May 2012. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Aldea (+34922678115, a.aldea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein/creatinine quotient and albumin/creatinine in matinal urine sample: basal and 3 period months after a month of the therapeutic protocol beginning. (time frame: 1-3 month). 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 21 May 2012.