Renal Insufficiency, ChronicPhase 1/2CKDuNCT01624064
Renal Effects of an Angiotensin Converting Enzyme Inhibitor in Adults With Chronic Kidney Disease of Uncertain Aetiology
A Phase 1/2 study testing Enalapril and Calcium Supplement in people with Renal Insufficiency, Chronic, run by Ministry of Health, Sri Lanka at 1 site in Sri Lanka.
Trial summary
Enalapril would significantly reduce progression of renal disease in patients with Chronic Kidney Disease of Uncertain aetiology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- Enalapril and Calcium Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSri Lanka
- Study dates
- Aug 2012to Oct 2013
- Phase
- Phase 1/2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between 18-70 years of age
- CKDu Grade 1, 2, 3
- No contraindication for treatment with ACEI
- Informed consent given
Who cannot join
- Grade 4 CKDu
- Other chronic diseases
- Evidence or suspicion of non renal secondary hypertension
- Diabetes type 1 or 2
- Evidence or suspicion of renovascular disease, obstructive uropathy, or other renal disease
- Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immune-suppressive drugs
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- Acute myocardial infarction or cerebrovascular accident in the previous 6 months
- Severe uncontrolled hypertension (diastolic blood pressure ≥115 and/or systolic blood pressure ≥220 mm Hg)
- Suspicion or evidence of connective tissue disease, cancer, higher serum aminotransferase concentrations
- Chronic cough; drug or alcohol abuse; pregnancy and breast feeding
- Unwillingness to sign informed consent
Trial locations and contacts
1 site in 1 country.
Sri Lanka1 site
General (Teaching) Hospital, Anuradhapura
Anuradhapura, North Central Province
Selvarajah Mathu, MBBS, MD, 94-77-7390628, mathuselvarajah@yahoo.com
Selvarajah Mathu, MBBS, MD
About this study
Official title: A Double Blind Clinical Trial to Examine the Renal Effects of an Angiotensin Converting Enzyme Inhibitor (Enalapril) in Adults With Chronic Kidney Disease of Uncertain Aetiology (CKDu)
Enalapril would significantly reduce progression of renal disease in patients with Chronic Kidney Disease of Uncertain aetiology.
Read the detailed description
End Stage Kidney Disease (ESKD) results in reduced life expectancy, quality of life and increased consumption of health care resources. Chronic Kidney Disease of Uncertain aetiology (CKDu) is being increasingly recognized in the North Central Region of Sri Lanka and in certain regions over 25% (unpublished data) of general population is suspected as suffering from CKDu. The number of patients who reach ESKD that requires hemodialysis or transplantation is increasing, highlighting the need to find strategies that slow progression of kidney disease. The need for these strategies is even more critical in Sri Lanka where dialysis in not a preferred treatment option. Treatment strategies should be readily accessible and cheap.
The importance of proteinuria as a significant risk factor for ESKD is well recognized, and treatment that is targeted at reducing proteinuria has been shown to reduce progression of renal disease. The Renin - Angiotensin - Aldosterone - System (RAAS) is directly involved in the regulation of blood pressure, fluid volume, and vascular response to injury and inflammation. The inappropriate activation of this system causes hypertension, fluid retention, and inflammatory, thrombotic, and atherogenic effects that may contribute to end-organ damage in the long term. Angiotensin II mediates hemodynamic effects as well as inflammation and fibrosis in the kidney, heart, and vasculature.
Numerous clinical trials have established that interruption of the RAAS cascade with angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) is beneficial in slowing progression of renal disease. Reduction of BP lowers proteinuria, but the use of an ACEI or an ARB reduces both proteinuria and the rate of deterioration of renal function beyond those seen with equivalent BP reduction from conventional antihypertensive agents. However, the use of these agents has limitations, with significant numbers of treated patients still demonstrating progressive renal disease. RAAS blockers have been shown to blunt the progression of advanced kidney disease. However the long-term renal effect of these agents in early renal disease is not well demonstrated. In fact the trials which showed benefits with RAAS blockers did show in glomerular disease and evidence is not so strong in tubulo-interstitial disease. The benefits of RAS inhibition seem to depend on the degree of proteinuria at baseline. It is marginal in those with low grade proteinuria.
In most forms of proteinuric chronic renal disease, glomerular filtration rate continues to decline even when the initial insult has been removed. The cause of CKDu is still unknown. CKDu is a tubulo-interstitial disease with low grade proteinuria. We believe that the place of ACEI for secondary prevention of CKDu progression needs investigation
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Enalapril, Calcium Supplement
- Keywords
- Renal Insufficiency, Chronic, Uncertain aetiology, ACEI
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnalaprilDrug
Also called Angiotensin Converting Enzyme Inhibitor
2.5-20 mg/day
Calcium SupplementDrug
Also called Calcium lactate
Calcium 2.5-20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Enalapril, Proteinuria < 1g/day | Active comparator | Not described Receives: Drug: Enalapril |
| Calcium, Proteinuria < 1g/day | Placebo comparator | Not described Receives: Drug: Calcium Supplement |
| Enalapril, Proteinuria > 1g/day | Active comparator | Not described Receives: Drug: Enalapril |
| Calcium, Proteinuria > 1g/day | Placebo comparator | Not described Receives: Drug: Calcium Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteinuria
Numerous clinical trials have established that angiotensin-converting enzyme inhibitors (ACEI) are beneficial in slowing progression of renal disease. However the long-term renal effect of these agents in early renal disease is not well demonstrated. In fact the trials which showed benefits with ACEI did show in glomerular disease and evidence is not so strong in tubulo-interstitial disease.
Measured: One year
Estimated GFR
In most forms of proteinuric chronic renal disease, glomerular filtration rate continues to decline even when the initial insult has been removed. The cause of CKDu is still unknown. CKDu is a tubulo-interstitial disease with low grade proteinuria. We believe that the place of ACEI for secondary prevention of CKDu progression needs investigation.
Measured: One year
Secondary outcomes (2)
All cause mortality
Measured: One year
Cardiovascular mortality
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startAug 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 Renal Insufficiency, 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Sri Lanka
- Sponsor type
- Other government
- Collaborators
- World Health Organization
- Responsible party
- Sponsor
- Investigators
- Selvarajah Mathu, MBBS, MD, Principal investigator, Ministry of HealthShanthi Mendis, MBBS, MD, Principal investigator, World Health OrganizationRezvi Sheriff, MBBS, MD, Principal investigator, University of ColomboThilak Abeysekera, MBBS, MD, Principal investigator, Ministry of HealthSaroj Jayasinghe, MBBS, MD, Principal investigator, University of Colombo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624064
- Sponsor's protocol ID
- NSF CKDu Research
- Acronym
- CKDu
- Status last verified
- Jun 2012
- First submitted
- 16 Jun 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Clinical Trial to Examine the Renal Effects of an Angiotensin Converting Enzyme Inhibitor (Enalapril) in Adults With Chronic Kidney Disease of Uncertain Aetiology (CKDu)
- ClinicalTrials.gov ID
- NCT01624064
- Acronym / sponsor ID
- CKDu / NSF CKDu Research
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Renal Insufficiency, Chronic, Uncertain aetiology, ACEI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ministry of Health, Sri LankaOther government
- Collaborators
- World Health Organization
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 20 Jun 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.
Enalapril would significantly reduce progression of renal disease in patients with Chronic Kidney Disease of Uncertain aetiology.
Detailed description
End Stage Kidney Disease (ESKD) results in reduced life expectancy, quality of life and increased consumption of health care resources. Chronic Kidney Disease of Uncertain aetiology (CKDu) is being increasingly recognized in the North Central Region of Sri Lanka and in certain regions over 25% (unpublished data) of general population is suspected as suffering from CKDu. The number of patients who reach ESKD that requires hemodialysis or transplantation is increasing, highlighting the need to find strategies that slow progression of kidney disease. The need for these strategies is even more critical in Sri Lanka where dialysis in not a preferred treatment option. Treatment strategies should be readily accessible and cheap.
The importance of proteinuria as a significant risk factor for ESKD is well recognized, and treatment that is targeted at reducing proteinuria has been shown to reduce progression of renal disease. The Renin - Angiotensin - Aldosterone - System (RAAS) is directly involved in the regulation of blood pressure, fluid volume, and vascular response to injury and inflammation. The inappropriate activation of this system causes hypertension, fluid retention, and inflammatory, thrombotic, and atherogenic effects that may contribute to end-organ damage in the long term. Angiotensin II mediates hemodynamic effects as well as inflammation and fibrosis in the kidney, heart, and vasculature.
Numerous clinical trials have established that interruption of the RAAS cascade with angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) is beneficial in slowing progression of renal disease. Reduction of BP lowers proteinuria, but the use of an ACEI or an ARB reduces both proteinuria and the rate of deterioration of renal function beyond those seen with equivalent BP reduction from conventional antihypertensive agents. However, the use of these agents has limitations, with significant numbers of treated patients still demonstrating progressive renal disease. RAAS blockers have been shown to blunt the progression of advanced kidney disease. However the long-term renal effect of these agents in early renal disease is not well demonstrated. In fact the trials which showed benefits with RAAS blockers did show in glomerular disease and evidence is not so strong in tubulo-interstitial disease. The benefits of RAS inhibition seem to depend on the degree of proteinuria at baseline. It is marginal in those with low grade proteinuria.
In most forms of proteinuric chronic renal disease, glomerular filtration rate continues to decline even when the initial insult has been removed. The cause of CKDu is still unknown. CKDu is a tubulo-interstitial disease with low grade proteinuria. We believe that the place of ACEI for secondary prevention of CKDu progression needs investigation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enalapril, Proteinuria < 1g/day | Active comparator | Drug: Enalapril |
| Calcium, Proteinuria < 1g/day | Placebo comparator | Drug: Calcium Supplement |
| Enalapril, Proteinuria > 1g/day | Active comparator | Drug: Enalapril |
| Calcium, Proteinuria > 1g/day | Placebo comparator | Drug: Calcium Supplement |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females between 18-70 years of age
- CKDu Grade 1, 2, 3
- No contraindication for treatment with ACEI
- Informed consent given
Key exclusion criteria (11 listed)
- Grade 4 CKDu
- Other chronic diseases
- Evidence or suspicion of non renal secondary hypertension
- Diabetes type 1 or 2
- Evidence or suspicion of renovascular disease, obstructive uropathy, or other renal 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 |
|---|---|---|
| EnalaprilAlso: Angiotensin Converting Enzyme Inhibitor2.5-20 mg/day | Drug | Enalapril, Proteinuria < 1g/day, Enalapril, Proteinuria > 1g/day |
| Calcium SupplementAlso: Calcium lactateCalcium 2.5-20 mg/day | Drug | Calcium, Proteinuria < 1g/day, Calcium, Proteinuria > 1g/day |
Primary outcome
Proteinuria
Time frame: One year
Numerous clinical trials have established that angiotensin-converting enzyme inhibitors (ACEI) are beneficial in slowing progression of renal disease. However the long-term renal effect of these agents in early renal disease is not well demonstrated. In fact the trials which showed benefits with ACEI did show in glomerular disease and evidence is not so strong in tubulo-interstitial disease.
Estimated GFR
Time frame: One year
In most forms of proteinuric chronic renal disease, glomerular filtration rate continues to decline even when the initial insult has been removed. The cause of CKDu is still unknown. CKDu is a tubulo-interstitial disease with low grade proteinuria. We believe that the place of ACEI for secondary prevention of CKDu progression needs investigation.
2 secondary outcomes
All cause mortality
Time frame: One year
Cardiovascular mortality
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 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.
Selvarajah Mathu, MBBS, MD principal investigator
Ministry of Health
Shanthi Mendis, MBBS, MD principal investigator
World Health Organization
Rezvi Sheriff, MBBS, MD principal investigator
University of Colombo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Enalapril and Calcium Supplement in people with Renal Insufficiency, Chronic, run by Ministry of Health, Sri Lanka at 1 site in Sri Lanka.
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 11 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 20 Jun 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 Sri Lanka. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Selvarajah Mathu, MBBS, MD (94-77-7390628, mathuselvarajah@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proteinuria (time frame: One year). The study lists 2 primary outcomes in all. 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 20 Jun 2012.