NephrocalcinosisPhase 3NCT00249951
Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
A Phase 3 study testing Alkaline citrate in people with Nephrocalcinosis, run by University of Cologne at 1 site in Germany.
Trial summary
Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. Read more about this study
- Who is it for?
- Ages 5 days to 8 weeks
- Conditions the study is for
- Nephrocalcinosis
- What is being tested?
- Alkaline citrate
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2005to Nov 2008
- 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 5 days to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants < 32 weeks gestation age and < 1500 g birth weight
Who cannot join
- Cardial, renal or gastrointestinal malformations
- Chronic renal failure
- Therapy with vitamin B6
- High dose treatment with furosemide or dexamethasone
- Addison's disease
- Severe metabolic alkalosis
- Worse clinical condition of preterm infant, which makes oral feeding impossible
- Participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.
- Conditions
- Nephrocalcinosis
- Being tested
- Alkaline citrate
- Keywords
- nephrocalcinosis, premature infants, hypocitraturia, alcaline citrate therapy, Nephrocalcinosis in premature infants
- Medical subject headings
- Nephrocalcinosis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkaline citrateDrug
Also called no brand names, Shol's solution versus placebo solution (NaCl 0.9 %)
Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of nephrocalcinosis
Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.
Measured: First eight weeks of life
Secondary outcomes (1)
Increase in urinary citrate excretion
Increase in urinary citrate excretion under prophylactic treatment
Measured: First eight weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. B. Hoppe, University of Cologne
- Investigators
- Bernd Hoppe, Prof. Dr., Principal investigator, University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249951
- Sponsor's protocol ID
- FG03-157
- Status last verified
- Jun 2012
- First submitted
- 3 Nov 2005
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sikora P, Roth B, Kribs A, Michalk DV, Hesse A, Hoppe B. Hypocitraturia is one of the major risk factors for nephrocalcinosis in very low birth weight (VLBW) infants. Kidney Int. 2003 Jun;63(6):2194-9. doi: 10.1046/j.1523-1755.2003.t01-4-00001.x.
PubMed 12753307Hoppe B, Duran I, Martin A, Kribs A, Benz-Bohm G, Michalk DV, Roth B. Nephrocalcinosis in preterm infants: a single center experience. Pediatr Nephrol. 2002 Apr;17(4):264-8. doi: 10.1007/s00467-001-0816-8.
PubMed 11956879Hoppe B, Roth B, Bauerfeld C, Langman CB. Oxalate, citrate, and sulfate concentration in human milk compared with formula preparations: influence on urinary anion excretion. J Pediatr Gastroenterol Nutr. 1998 Oct;27(4):383-6. doi: 10.1097/00005176-199810000-00002.
PubMed 9779963Hoppe B, Hesse A, Neuhaus T, Fanconi S, Forster I, Blau N, Leumann E. Urinary saturation and nephrocalcinosis in preterm infants: effect of parenteral nutrition. Arch Dis Child. 1993 Sep;69(3 Spec No):299-303. doi: 10.1136/adc.69.3_spec_no.299.
PubMed 8215570
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alkaline Citrate Treatment to Lower the Risk of Nephrocalcinosis in Preterm Infants
- ClinicalTrials.gov ID
- NCT00249951
- Acronym / sponsor ID
- FG03-157
- Conditions
- Nephrocalcinosis
- Keywords
- nephrocalcinosis, premature infants, hypocitraturia, alcaline citrate therapy, Nephrocalcinosis in premature infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Nov 2005 (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.
Preterm infants are at risk to develop nephrocalcinosis. Incidence numbers vary according to birth weight and gestation age. Very low birth weight infants have the highest risk index, with ~ 7-10 % of preterm infants developing nephrocalcinosis in the patient population. We, the researchers at the University of Cologne, and others found significantly decreased urinary citrate excretion (hypocitraturia) to be one of the main risk factors. Hence, we hypothesized, that prophylactic treatment with oral alkaline citrate solution (Shol's solution) would help to 1) increase urinary citrate excretion and 2) help to decrease the incidence of nephrocalcinosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 5 days to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants < 32 weeks gestation age and < 1500 g birth weight
Key exclusion criteria (8 listed)
- Cardial, renal or gastrointestinal malformations
- Chronic renal failure
- Therapy with vitamin B6
- High dose treatment with furosemide or dexamethasone
- Addison's disease
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 |
|---|---|---|
| Alkaline citrateAlso: no brand names, Shol's solution versus placebo solution (NaCl 0.9 %)Prophylactic alkaline citrate medication during the first 8 weeks of life versus placebo solution to prevent nephrocalcinosis of prematurity. | Drug | – |
Primary outcome
Prevention of nephrocalcinosis
Time frame: First eight weeks of life
Prevention of the development of nephrocalcinosis under prophylactic treatment with an alkaline citrate prepration.
1 secondary outcome
Increase in urinary citrate excretion
Time frame: First eight weeks of life
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 3 Jul 2012.
- Background: PubMed 12753307Sikora P, Roth B, Kribs A, Michalk DV, Hesse A, Hoppe B. Hypocitraturia is one of the major risk factors for nephrocalcinosis in very low birth weight (VLBW) infants. Kidney Int. 2003 Jun;63(6):2194-9. doi: 10.1046/j.1523-1755.2003.t01-4-00001.x.
- Background: PubMed 11956879Hoppe B, Duran I, Martin A, Kribs A, Benz-Bohm G, Michalk DV, Roth B. Nephrocalcinosis in preterm infants: a single center experience. Pediatr Nephrol. 2002 Apr;17(4):264-8. doi: 10.1007/s00467-001-0816-8.
- Background: PubMed 9779963Hoppe B, Roth B, Bauerfeld C, Langman CB. Oxalate, citrate, and sulfate concentration in human milk compared with formula preparations: influence on urinary anion excretion. J Pediatr Gastroenterol Nutr. 1998 Oct;27(4):383-6. doi: 10.1097/00005176-199810000-00002.
- Background: PubMed 8215570Hoppe B, Hesse A, Neuhaus T, Fanconi S, Forster I, Blau N, Leumann E. Urinary saturation and nephrocalcinosis in preterm infants: effect of parenteral nutrition. Arch Dis Child. 1993 Sep;69(3 Spec No):299-303. doi: 10.1136/adc.69.3_spec_no.299.
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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.
Bernd Hoppe, Prof. Dr. principal investigator
University Children's Hospital Cologne, Kerpenerstr. 62, D-50924 Cologne, Germany
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 Alkaline citrate in people with Nephrocalcinosis, run by University of Cologne at 1 site in Germany.
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 1 inclusion and 8 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 3 Jul 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 Germany. 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?
Prevention of nephrocalcinosis (time frame: First eight weeks of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249951, which also lists 4 linked publications.
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 3 Jul 2012.