NephrocalcinosisPhase 3PRENECALNCT01756547
Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature
A Phase 3 study testing Potassium Citrate in people with Nephrocalcinosis, run by Juan A. Arnaiz at 1 site in Spain.
Trial summary
Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial. Read more about this study
- Who is it for?
- Ages 7 days to 16 weeks
- Conditions the study is for
- Nephrocalcinosis
- What is being tested?
- Potassium Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Jan 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 7 days to 16 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants of both sexes born at the Hospital Clinic of Barcelona.
- Corrected gestational age below 32 weeks and lower birth weight 1500gr.
- Survivors at 7 days old.
- Clinically stable, in the opinion of the investigator, at the time of inclusion.
- That, properly informed, parents and / or legal guardians give written consent to allow the participation of the infant in the study and submit to the tests and examinations that it entails
Who cannot join
- Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
- Chronic renal failure (serum creatinine> 1.5 mg / dL or an increase of 0.3 mg / dL / day and / or oliguria defined as diuresis <0.5 mL / kg / hour after the first day of life)
- Treatment with furosemide or dexamethasone
- Addison's disease.
- Persistent severe metabolic alkalosis.
- Impossibility of oral feeding.
Trial locations and contacts
1 site in 1 country.
Francisco Botet Mussons, MD contact
Spain1 site
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Judit Pich Martínez, Pharmacist, 0034 93 227 54 00 ext. 2815, jpich@clinic.ub.es
Francisco Botet Mussons, MD, fbotet@clinic.ub.es
About this study
Official title: Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature.
Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial.
- Conditions
- Nephrocalcinosis
- Being tested
- Potassium Citrate, Placebo
- Keywords
- Nephrocalcinosis, Extreme premature
- Medical subject headings
- Nephrocalcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Potassium CitrateDrug
Potassium citrate, oral solution contains Tripotassium citrate monohydrate 20 grams, Citric acid monohydrate 4 grams, distilled water 40 ml, and simple syrup 100ml. The solution contained in a bottle of glass that contains 20 ml of 2 meq/ml of potassium and 2.5 meq/ml of citrate. The dose is 0,3ml/kg/day of the solution until the 38-40 weeks of corrected gestational age or unacceptable toxicity develops.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Potassium citrate | Experimental | Potassium citrate, oral solution contains Tripotassium citrate monohydrate 20 grams, Citric acid monohydrate 4 grams, distilled water 40 ml, and simple syrup 100ml. The solution contained in a bottle of glass that contains 20 ml of 2 meq/ml of potassium and 2.5 meq/ml of citrate. The dose is 0,3ml/kg/day of the solution until the 38-40 weeks of corrected gestational age. Receives: Drug: Potassium Citrate |
| Placebo | Placebo comparator | Oral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of nephrocalcinosis in extremely preterm infants
incidence of nephrocalcinosis in extremely preterm infants
Measured: 38-40 weeks of corrected gestational age
Secondary outcomes (4)
Determine whether the administration of potassium citrate in extreme premature decreases neonates the levels of calcium and calcium / creatinine ratio in urine in each of the branches of treatment at 38-40 weeks
Determine whether the administration of potassium citrate in extreme premature decreases neonates the levels of calcium and calcium / creatinine ratio in urine in each of the branches of treatment at 38-40 weeks
Measured: 38-40 weeks of corrected gestational age
To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value
To determine whether administration of potassium citrate in extreme premature infants improves the levels of phosphorus, potassium, sodium, citrate, creatinine, oxalate, and ratio citrate / calcium and ph in urine in each treatment arm at the 38-40 weeks.
Measured: 38-40 weeks of corrected gestational age
Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value.
Determine whether the administration of potassium citrate in extreme premature neonates improves the plasma levels of sodium, potassium, creatinine, calcium, and blood ph value in each of the branches of treatment at 38-40 weeks.
Measured: 38-40 weeks of corrected gestational age
To determine the incidence of adverse events and serious adverse events related to study treatment.
To determine the incidence of adverse events and serious adverse events related to study treatment.
Measured: 38-40 weeks of corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrocalcinosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan A. Arnaiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
- Investigators
- Francisco Botet Mussons, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756547
- Sponsor's protocol ID
- PRENECAL
- Acronym
- PRENECAL
- Status last verified
- Dec 2012
- First submitted
- 20 Dec 2012
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature.
- ClinicalTrials.gov ID
- NCT01756547
- Acronym / sponsor ID
- PRENECAL / PRENECAL
- Conditions
- Nephrocalcinosis
- Keywords
- Nephrocalcinosis, Extreme premature
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Juan A. ArnaizUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 27 Dec 2012 (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.
Study to assess the efficacy and safety of oral potassium citrate on the Prevention of nephrocalcinosis in extreme premature: a clinical trial, randomized, double-blind placebo controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Potassium citrate | Experimental | Drug: Potassium CitratePotassium citrate, oral solution contains Tripotassium citrate monohydrate 20 grams, Citric acid monohydrate 4 grams, distilled water 40 ml, and simple syrup 100ml. The solution contained in a bottle of glass that contains 20 ml of 2 meq/ml of potassium and 2.5 meq/ml of citrate. The dose is 0,3ml/kg/day of the solution until the 38-40 weeks of corrected gestational age. |
| Placebo | Placebo comparator | Drug: PlaceboOral solution 30ml, that contains distilled water and simple syrup, in the same dose like the active treatment 0,3ml/kg/day. |
Who may qualify
- Ages
- 7 days to 16 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Premature infants of both sexes born at the Hospital Clinic of Barcelona.
- Corrected gestational age below 32 weeks and lower birth weight 1500gr.
- Survivors at 7 days old.
- Clinically stable, in the opinion of the investigator, at the time of inclusion.
- That, properly informed, parents and / or legal guardians give written consent to allow the participation of the infant in the study and submit to the tests and examinations that it entails
Key exclusion criteria (6 listed)
- Renal malformations, cardiac or gastrointestinal prenatal or postnatal diagnosis.
- Chronic renal failure (serum creatinine> 1.5 mg / dL or an increase of 0.3 mg / dL / day and / or oliguria defined as diuresis <0.5 mL / kg / hour after the first day of life)
- Treatment with furosemide or dexamethasone
- Addison's disease.
- Persistent severe metabolic alkalosis.
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 |
|---|---|---|
| Potassium CitratePotassium citrate, oral solution contains Tripotassium citrate monohydrate 20 grams, Citric acid monohydrate 4 grams, distilled water 40 ml, and simple syrup 100ml. The solution contained in a bottle of glass that contains 20 ml of 2 meq/ml of potassium and 2.5 meq/ml of citrate. The dose is 0,3ml/kg/day of the solution until the 38-40 weeks of corrected gestational age or unacceptable toxicity develops. | Drug | Potassium citrate |
| Placebo | Drug | Placebo |
Primary outcome
incidence of nephrocalcinosis in extremely preterm infants
Time frame: 38-40 weeks of corrected gestational age
incidence of nephrocalcinosis in extremely preterm infants
4 secondary outcomes
Determine whether the administration of potassium citrate in extreme premature decreases neonates the levels of calcium and calcium / creatinine ratio in urine in each of the branches of treatment at 38-40 weeks
Time frame: 38-40 weeks of corrected gestational age
To determine whether administration of potassium citrate improves the levels of urinary phosphorus, potassium, sodium, citrate, creatinine, oxalate, ratio citrate / calcium , and ph value
Time frame: 38-40 weeks of corrected gestational age
Determine whether the administration of potassium citrate improves the plasma levels of sodium, potassium, creatinine, calcium, and ph value.
Time frame: 38-40 weeks of corrected gestational age
To determine the incidence of adverse events and serious adverse events related to study treatment.
Time frame: 38-40 weeks of corrected gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
Related trials for Nephrocalcinosis
Not yet recruitingObservational study
Diagnostic Work-up of Nephrocalcinosis in Children
Nephrocalcinosis
Enrolling by invitationObservational study
Epidemiology and Risk Factors of Nephrolithiasis and Nephrocalcinosis With Pediatric Onset
Nephrocalcinosis
RecruitingPhase 2
Rifampin in CYP24A1-related Hypercalcemia and Hypercalciuria
Idiopathic Infantile Hypercalcaemia - Severe Form, Genetic Disease
Not yet recruitingPhase 2/3
The GranStone Trial
Paraffinoma, Granuloma, Foreign-Body
Active, not recruitingPhase 3
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
Autosomal Dominant Hypocalcemia (ADH)
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.
Francisco Botet Mussons, MD contact
Francisco Botet Mussons, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Potassium Citrate in people with Nephrocalcinosis, run by Juan A. Arnaiz at 1 site 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 6 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 27 Dec 2012. 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 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judit Pich Martínez, Pharmacist (0034 93 227 54 00 ext. 2815, jpich@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of nephrocalcinosis in extremely preterm infants (time frame: 38-40 weeks of corrected gestational age). 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 27 Dec 2012.