MicroalbuminuriaEND-ITNCT00907374
Low Dose Versus Aggressive Inhibition of the Renin-Angiotensin-Aldosterone (RAS) to Treat Microalbuminuria
A study testing benazepril in people with Microalbuminuria, run by Charles Drew University of Medicine and Science at 1 site in United States.
Trial summary
The objective of the study is to assess the effect of standard versus aggressive inhibition of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA) on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR), c)endothelial dysfunction (measured by… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Microalbuminuria
- What is being tested?
- benazepril
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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, age 18-70
- Subjects with diabetic renal disease as defined by spot urine albumin - creatinine ratio 30-300mg/g and estimated glomerular filtration rate of >60 ml/min
Who cannot join
- Intake of non-steroidal anti-inflammatory agents (NSAIDs) more than 15 days/month, excluding aspirin.
- Inability to discontinue NSAIDs or aspirin for 5 days prior to GFR measurement.
- History of severe adverse reaction to any of the randomized drugs required for use in the protocol or contraindication of their use.
- Participation in another intervention study.
- Pregnancy or likelihood of becoming pregnant during the study period; lactation
- Clinical and laboratory evidence of any renal disease other than diabetic nephropathy.
Show all 13Show fewer
- History of drug abuse in the past 2 years, including narcotics, cocaine or alcohol (> 21 drinks per week). Serious systemic disease that might influence survival or the course of renal disease. (Chronic oral steroid therapy is exclusion, but steroid-containing nasal sprays are not. Inactive sarcoidosis is not an exclusion).
- History of malignant or accelerated hypertension within 6 months prior to study entry; previous chronic peritoneal or hemodialysis or renal transplantation. Known secondary causes of hypertension. Spot urine albumin - creatinine ratio exceeding 300 (mg/g)
- Serum potassium level > 5.5 mEq/L for those not on ACE inhibitors during Baseline, or serum potassium level > 5.9 mEq/L for those on ACE inhibitors during Baseline.
- Leukopenia < 2,500/mm3 at screening and confirmed at the end of Baseline.
- Doubt that the participant will be able to adhere to medications or comply with the protocol visit schedule
- Arm Circumference > 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff. Arm length such that if the cuff circumference extended into the antecubital space so that the cuff interfered with placement of the stethoscope over the brachial artery for blood pressure measurement
- Clinical evidence of lead intoxication. Clinical evidence of congestive heart failure, current or within the preceding six months. Ejection fraction below 35% measured by any method. Heart block greater than first degree or any other arrhythmia that contraindicated the use of any of the primary BP drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles Drew University
Los Angeles, California, 90059
About this study
Official title: Early Nephropathy Study in Diabetes With Inhibitory Renin-Angiotensin-Aldosterone System Therapy (END-IT)
The objective of the study is to assess the effect of standard versus aggressive inhibition of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA) on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR), c)endothelial dysfunction (measured by post-hyperemia arterial tonometry) and d)the slowing of the progression of atherosclerotic disease (measured by carotid intima media thickness [CIMT]).
Read the detailed description
Diabetic patients with confirmed MA (50-300 mg albumin per g creatinine) on a morning spot urine sample were entered into a one to three month run-in phase before randomization. (50 mg/g was used as the lower limit to allow room for improvement to reach normal.) Since hypertension and uncontrolled hyperglycemia will cause MA, blood pressure (BP) and hemoglobin A1c (AIC) levels were reduced to <130/80 mm Hg and <8.0%, respectively, during this period. All patients had been on various doses of an angiotensin converting enzyme inhibitor (ACE-I) which were reduced to 10 mg benazepril and BP controlled with other classes of anti-hypertensive drugs (except for angiotensin receptor blockers [ARB's]). Glycemia was treated with intensification of their current therapy. MA and BP were measured monthly.
When goal levels of BP and AIC were achieved and MA was still present, patients were randomized to either low dose RAS inhibition (10 mg benazepril) (Standard) or aggressive inhibition of the RAS (Aggressive). MA continued to be measured monthly and the progressive increase in doses of an ACE-I and an ARB was as follows. Benazepril (the ACE-I) - 10 mg to 20 mg to 40 mg to adding losartan (the ARB) -25 mg to 50 mg to 100 mg to increasing benazepril to 80 mg with the goal of returning albumin excretion to normal. Other classes of drugs were reduced as necessary to keep systolic BP > 100 mm Hg. Serum creatinine and potassium[K+] were measured monthly, AIC levels every 3 months and CIMT by ultrasound and endothelial function by post hyperemia and nitroglycerine (NTG) - induced peripheral artery tonometry (PAT) via finger plethysmography every six months.
- Conditions
- Microalbuminuria
- Being tested
- benazepril
- Keywords
- Microalbuminuria, Carotid intima media thickness, Endothelial dysfunction, Renin angiotensin system, Diabetic nephropathy
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
benazeprilDrug
Also called Lotensin
benazepril 10 mg orally once daily
benazeprilDrug
Also called Lotensin, Cozaar
40-80 mg benazepril plus 25-100 mg losartan orally once or twice daily
| Study group | Role | What they receive |
|---|---|---|
| Low dose inhibition of RAS | Active comparator | Standard low dose inhibition of the RAS with 10 mg of benazepril orally daily to treat microalbuminuria Receives: Drug: benazepril |
| Agressive inhibition of the RAS | Experimental | 40-80 mg benazepril plus 25-100 mg losartan both orally once or twice daily Receives: Drug: benazepril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio
Average of ratio for all participants during the 3-36 months of the study
Measured: 3 to 36 months
Secondary outcomes (3)
Estimated Glomerular Filtration Rate
This is an average for all participants during the 3-36 month study period
Measured: 3 to 36 months
Carotid Artery Intima Thickness
Thickness of intima of right carotid artery; average of all particpants from 6-36 months of study
Measured: 6 to 36 months
Endothelial Dysfunction
Post hyperemia increase in blood flow - fold increase from before and after occluding BP; values are mean of all participants in 6-36 months of study period.
Measured: 6 to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startJul 2005
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles Drew University of Medicine and Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mayer Davidson, Charles Drew University of Medicine and Science
- Investigators
- Naureen Taureen, MD, Principal investigator, Charles Drew UniversityMayer B. Davidson, MD, Study director, Charles Drew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907374
- Sponsor's protocol ID
- IRB# 04-09-772
- Other IDs
- U54RR014616
- Acronym
- END-IT
- Status last verified
- Mar 2012
- First submitted
- 21 May 2009
- Last updated
- 30 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Nephropathy Study in Diabetes With Inhibitory Renin-Angiotensin-Aldosterone System Therapy (END-IT)
- ClinicalTrials.gov ID
- NCT00907374
- Acronym / sponsor ID
- END-IT / IRB# 04-09-772
- Conditions
- Microalbuminuria
- Keywords
- Microalbuminuria, Carotid intima media thickness, Endothelial dysfunction, Renin angiotensin system, Diabetic nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Charles Drew University of Medicine and ScienceUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 May 2009 (estimated)
- Results
- Posted 30 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess the effect of standard versus aggressive inhibition of the renin-angiotensin system (RAS)in type 2 diabetic patients with microalbuminuria (MA) on; a)progression of microalbuminuria, b)estimated glomerular filtration rate (eGFR), c)endothelial dysfunction (measured by post-hyperemia arterial tonometry) and d)the slowing of the progression of atherosclerotic disease (measured by carotid intima media thickness [CIMT]).
Detailed description
Diabetic patients with confirmed MA (50-300 mg albumin per g creatinine) on a morning spot urine sample were entered into a one to three month run-in phase before randomization. (50 mg/g was used as the lower limit to allow room for improvement to reach normal.) Since hypertension and uncontrolled hyperglycemia will cause MA, blood pressure (BP) and hemoglobin A1c (AIC) levels were reduced to <130/80 mm Hg and <8.0%, respectively, during this period. All patients had been on various doses of an angiotensin converting enzyme inhibitor (ACE-I) which were reduced to 10 mg benazepril and BP controlled with other classes of anti-hypertensive drugs (except for angiotensin receptor blockers [ARB's]). Glycemia was treated with intensification of their current therapy. MA and BP were measured monthly.
When goal levels of BP and AIC were achieved and MA was still present, patients were randomized to either low dose RAS inhibition (10 mg benazepril) (Standard) or aggressive inhibition of the RAS (Aggressive). MA continued to be measured monthly and the progressive increase in doses of an ACE-I and an ARB was as follows. Benazepril (the ACE-I) - 10 mg to 20 mg to 40 mg to adding losartan (the ARB) -25 mg to 50 mg to 100 mg to increasing benazepril to 80 mg with the goal of returning albumin excretion to normal. Other classes of drugs were reduced as necessary to keep systolic BP > 100 mm Hg. Serum creatinine and potassium[K+] were measured monthly, AIC levels every 3 months and CIMT by ultrasound and endothelial function by post hyperemia and nitroglycerine (NTG) - induced peripheral artery tonometry (PAT) via finger plethysmography every six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose inhibition of RAS | Active comparator | Drug: benazeprilStandard low dose inhibition of the RAS with 10 mg of benazepril orally daily to treat microalbuminuria |
| Agressive inhibition of the RAS | Experimental | Drug: benazepril40-80 mg benazepril plus 25-100 mg losartan both orally once or twice daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females, age 18-70
- Subjects with diabetic renal disease as defined by spot urine albumin - creatinine ratio 30-300mg/g and estimated glomerular filtration rate of >60 ml/min
Key exclusion criteria (13 listed)
- Intake of non-steroidal anti-inflammatory agents (NSAIDs) more than 15 days/month, excluding aspirin.
- Inability to discontinue NSAIDs or aspirin for 5 days prior to GFR measurement.
- History of severe adverse reaction to any of the randomized drugs required for use in the protocol or contraindication of their use.
- Participation in another intervention study.
- Pregnancy or likelihood of becoming pregnant during the study period; lactation
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 |
|---|---|---|
| benazeprilAlso: Lotensinbenazepril 10 mg orally once daily | Drug | Low dose inhibition of RAS |
| benazeprilAlso: Lotensin, Cozaar40-80 mg benazepril plus 25-100 mg losartan orally once or twice daily | Drug | Agressive inhibition of the RAS |
Primary outcome
Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio
Time frame: 3 to 36 months
Average of ratio for all participants during the 3-36 months of the study
3 secondary outcomes
Estimated Glomerular Filtration Rate
Time frame: 3 to 36 months
Carotid Artery Intima Thickness
Time frame: 6 to 36 months
Endothelial Dysfunction
Time frame: 6 to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Microalbuminuria
Not yet recruitingObservational study
Diastolic Dysfunction and Pulmonary Hypertension in T2DM With Microalbuminuria
Diabetes Mellitus Type 2
RecruitingPhase 1
Time Restricted Eating in Patients With Microalbuminuria
Type 2 Diabetes Mellitus (T2DM), Time Restricted Eating
Recruiting
New Taipei City 888 Digital Medical AI Platform for Prevention and Care of the Three Highs and Cardio-Renal-Vascular Diseases
Microalbuminuria, Microalbuminuria /Creatinine Ratios ACR
RecruitingPhase 4
ACE Reno, Pico Cell Matrix and Its Effect on eGFR in Chronic Kidney Diseases
Hypertensive Nephropathy, Auto Immune Disorders
Enrolling by invitationObservational study
Risk Factors at Chronic Non-communicable Diseases in People of Working Age
Chronic Non-communicable Disease
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.
Naureen Taureen, MD principal investigator
Charles Drew University
Mayer B. Davidson, MD study director
Charles Drew University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing benazepril in people with Microalbuminuria, run by Charles Drew University of Medicine and Science at 1 site in United States.
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 2 inclusion and 13 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 30 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 30 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Microalbuminuria Reported as Urinary Albumin:Creatinine Ratio (time frame: 3 to 36 months). 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 30 Mar 2012.