MicroalbuminuriaNCT01891292
Efficacy of Antioxidant Therapy Compared With Enalapril in Sickle Nephropathy
A study testing Enalapril and N-Acetylcysteine in people with Microalbuminuria and Sickle Cell Nephropathy, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Microalbuminuria, Sickle Cell Nephropathy
- What is being tested?
- Enalapril and N-Acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJamaica
- Study dates
- Jul 2013to Sep 2015
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Homozygous S sickle cell disease
- Diagnosed by newborn screening
- determined to have persistent microalbuminuria
- satisfied criteria for microalbuminuria screening
- parental consent
Who cannot join
- Asymptomatic bacteriuria on screening urine cultures
- On Hydroxyurea therapy
- Pre-existing complications of SCD which would meet local criteria for HU therapy
Trial locations and contacts
1 site in 1 country.
Jamaica1 site
Sickle Cell Unit
Kingston
Lesley King, MB.BS, 8769272471, lesley.king@uwimona.edu.jm
Marvin Reid, MB.BS, 8769272471, marvin.reid@uwimona.edu.jm
About this study
Official title: A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children
The purpose of this study is to determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy
- Conditions
- Microalbuminuria, Sickle Cell Nephropathy
- Being tested
- Enalapril, N-Acetylcysteine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
0.25-0.35 mg/kg/day
N-AcetylcysteineDrug
N-Acetylcysteine 0.5 mmol/kg
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Enalapril | Active comparator | Not described Receives: Drug: Enalapril |
| N-Acetylcysteine | Active comparator | Not described Receives: Drug: N-Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary albumin excretion rate
Measured: 12 months
Secondary outcomes (1)
Glomerular filtration rate
Measurement of glomerular filtration rate by iohexol
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicroalbuminuriaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Collaborators
- Caribbean Health Research Council
- Responsible party
- Principal investigator, Marvin Reid, The University of The West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891292
- Sponsor's protocol ID
- ECP 172, 10/11
- Status last verified
- Jun 2013
- First submitted
- 22 Jan 2013
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sasongko TH, Nagalla S. Angiotensin-converting enzyme (ACE) inhibitors for proteinuria and microalbuminuria in people with sickle cell disease. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD009191. doi: 10.1002/14651858.CD009191.pub4.
PubMed 34932828
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of the Efficacy of Antioxidant Therapy Compared With Enalapril in Slowing the Progression of Sickle Nephropathy in Children
- ClinicalTrials.gov ID
- NCT01891292
- Acronym / sponsor ID
- ECP 172, 10/11
- Conditions
- Microalbuminuria, Sickle Cell Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Collaborators
- Caribbean Health Research Council
- Study start
- Jul 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 3 Jul 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 determine whether enalapril or antioxidant therapy (N-Acetylcysteine) is effective in reducing microalbuminuria in children with sickle cell disease and and its progression to sickle nephropathy
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Enalapril | Active comparator | Drug: Enalapril |
| N-Acetylcysteine | Active comparator | Drug: N-Acetylcysteine |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Homozygous S sickle cell disease
- Diagnosed by newborn screening
- determined to have persistent microalbuminuria
- satisfied criteria for microalbuminuria screening
- parental consent
Key exclusion criteria (3 listed)
- Asymptomatic bacteriuria on screening urine cultures
- On Hydroxyurea therapy
- Pre-existing complications of SCD which would meet local criteria for HU therapy
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 |
|---|---|---|
| Enalapril0.25-0.35 mg/kg/day | Drug | Enalapril |
| N-AcetylcysteineN-Acetylcysteine 0.5 mmol/kg | Drug | N-Acetylcysteine |
Primary outcome
urinary albumin excretion rate
Time frame: 12 months
1 secondary outcome
Glomerular filtration rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
- Derived from this study: PubMed 34932828Sasongko TH, Nagalla S. Angiotensin-converting enzyme (ACE) inhibitors for proteinuria and microalbuminuria in people with sickle cell disease. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD009191. doi: 10.1002/14651858.CD009191.pub4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enalapril and N-Acetylcysteine in people with Microalbuminuria and Sickle Cell Nephropathy, run by The University of The West Indies at 1 site in Jamaica.
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 3 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 3 Jul 2013. 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 Jamaica. 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.
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 Lesley King, MB.BS (976-927-2471, lesley.king@uwimona.edu.jm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary albumin excretion rate (time frame: 12 months). 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 NCT01891292, which also lists 1 linked publication.
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 2013.