Renal Insufficiency, ChronicSDBRASNCT00630708
Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency
A study testing Benazepril, Losartan and Benazepril+Losartan in people with Renal Insufficiency, Chronic, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency. 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?
- Benazepril, Losartan and Benazepril+Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteChina
- Study dates
- Feb 2008to Mar 2014
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum creatinine concentration of 3.0 to 5.0 mg per deciliter (265 to 442 µmol/L)
- Creatinine clearance of 15 to 30 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
- non-diabetic renal disease
- Persistent heavier proteinuria (defined by urinary protein excretion of more than 0.3g per day for three or more months without evidence of urinary tract infection or overt heart failure [a New York Heart Association class of Ⅲ or Ⅳ])
- had not received ACE inhibitors or ARBs for at least two weeks before screening
Who cannot join
- No history of allergic reaction to drugs, especially ACE inhibitors and/or ARBs
- Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
- Malignant hypertension (blood pressure >180/120 mm Hg) or blood pressure <110mm Hg without antihypertensive treatment
- Treatment with drugs affecting serum potassium such as diuretic, β2 receptor blocker et al.
- Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs, especially ciclosporin A
- Myocardial infarction or cerebrovascular accident in the year preceding the trial
Show all 11Show fewer
- Nephrotic syndrome (albuminaemia less than 25 g/L)
- Renovascular disease or connective-tissue disease
- Obstructive uropathy
- Immediate need for dialysis
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
Renal Division, Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, 510515
About this study
The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.
Read the detailed description
Interruption of the renin-angiotensin systerm (RAS) with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) slows the progression of chronic renal insufficiency in the presence or absence of diabetes. Even for advanced chronic renal insufficiency (stage 4 CKD), ACE inhibitors and ARBs can still provide renoprotection. Some clinical studies showed that dual RAS blockage seemed to enhance the antiproteinuric effect compared with single-agent ACE inhibitor or ARB and then improve renal survival. However, in the only one randomized controlled trial investigating the renoprotection of combined ACE inhibitor and ARB for mild or moderate chronic renal insufficiency (the mean creatinine value is 2.9mg/dl), the incidence of hyperkalemia was increased in combination therapy compared with monotherapy. Although increase of hyperkalemia was not statistical significant, it suggested that combination treatment of ACEI and ARB might increase the incidence of hyperkalemia in patients with advanced renal insufficiency. However, it is still undetermined whether combination treatment of ACE inhibitor and ARB is safe as an ACE inhibitor or ARB monotherapy in advanced non-diabetic chronic renal insufficiency (stage 4 CKD). The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.
- Conditions
- Renal Insufficiency, Chronic
- Being tested
- Benazepril, Losartan, Benazepril+Losartan
- Keywords
- Renal insufficiency, Benazepril, Losartan, combination treatment, Safety
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenazeprilDrug
Also called Lotensin
20 mg per day
LosartanDrug
Also called Cozaar
100 mg per day
Benazepril+LosartanDrug
Also called Lotensin+Cozaar
combination treatment of 10 mg benazepril and 50 mg losartan per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Benazepril group Receives: Drug: Benazepril |
| 2 | Active comparator | Losartan group Receives: Drug: Losartan |
| 3 | Active comparator | Benazepril+Losartan group Receives: Drug: Benazepril+Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with increase in serum potassium ≥6.0 mmol/L.
Measured: Every 4 weeks
Secondary outcomes (4)
The proportion of patients with serum creatinine increase >30%
Measured: Every 4 weeks
The proportion of patients with drug-related cough
Measured: Every 4 weeks
The proportion of patients with hopotension (systolic blood pressure <110 mmHg despite withdrawal of all additional antihypertensive medication)
Measured: Every 4 weeks
The proportion of patients with non-fatal cardiovascular events
Measured: Every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Significant differences observed between groups.
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.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- 309 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fan Fan Hou, M.D.,Ph.D., Principal investigator, Renal Division, Nanfang Hospital,Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630708
- Sponsor's protocol ID
- Nanfang200803
- Acronym
- SDBRAS
- Status last verified
- Apr 2016
- First submitted
- 28 Feb 2008
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency
- ClinicalTrials.gov ID
- NCT00630708
- Acronym / sponsor ID
- SDBRAS / Nanfang200803
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Renal insufficiency, Benazepril, Losartan, combination treatment, Safety
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant differences observed between groups.
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Mar 2008 (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 primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.
Detailed description
Interruption of the renin-angiotensin systerm (RAS) with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) slows the progression of chronic renal insufficiency in the presence or absence of diabetes. Even for advanced chronic renal insufficiency (stage 4 CKD), ACE inhibitors and ARBs can still provide renoprotection. Some clinical studies showed that dual RAS blockage seemed to enhance the antiproteinuric effect compared with single-agent ACE inhibitor or ARB and then improve renal survival. However, in the only one randomized controlled trial investigating the renoprotection of combined ACE inhibitor and ARB for mild or moderate chronic renal insufficiency (the mean creatinine value is 2.9mg/dl), the incidence of hyperkalemia was increased in combination therapy compared with monotherapy. Although increase of hyperkalemia was not statistical significant, it suggested that combination treatment of ACEI and ARB might increase the incidence of hyperkalemia in patients with advanced renal insufficiency. However, it is still undetermined whether combination treatment of ACE inhibitor and ARB is safe as an ACE inhibitor or ARB monotherapy in advanced non-diabetic chronic renal insufficiency (stage 4 CKD). The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: BenazeprilBenazepril group |
| 2 | Active comparator | Drug: LosartanLosartan group |
| 3 | Active comparator | Drug: Benazepril+LosartanBenazepril+Losartan group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Serum creatinine concentration of 3.0 to 5.0 mg per deciliter (265 to 442 µmol/L)
- Creatinine clearance of 15 to 30 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
- non-diabetic renal disease
- Persistent heavier proteinuria (defined by urinary protein excretion of more than 0.3g per day for three or more months without evidence of urinary tract infection or overt heart failure [a New York Heart Association class of Ⅲ or Ⅳ])
- had not received ACE inhibitors or ARBs for at least two weeks before screening
Key exclusion criteria (11 listed)
- No history of allergic reaction to drugs, especially ACE inhibitors and/or ARBs
- Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
- Malignant hypertension (blood pressure >180/120 mm Hg) or blood pressure <110mm Hg without antihypertensive treatment
- Treatment with drugs affecting serum potassium such as diuretic, β2 receptor blocker et al.
- Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs, especially ciclosporin A
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: Lotensin20 mg per day | Drug | 1 |
| LosartanAlso: Cozaar100 mg per day | Drug | 2 |
| Benazepril+LosartanAlso: Lotensin+Cozaarcombination treatment of 10 mg benazepril and 50 mg losartan per day | Drug | 3 |
Primary outcome
The proportion of patients with increase in serum potassium ≥6.0 mmol/L.
Time frame: Every 4 weeks
4 secondary outcomes
The proportion of patients with serum creatinine increase >30%
Time frame: Every 4 weeks
The proportion of patients with drug-related cough
Time frame: Every 4 weeks
The proportion of patients with hopotension (systolic blood pressure <110 mmHg despite withdrawal of all additional antihypertensive medication)
Time frame: Every 4 weeks
The proportion of patients with non-fatal cardiovascular events
Time frame: Every 4 weeks
Results and safety
The study was stopped early (reason given: Significant differences observed between groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
Related trials for Renal Insufficiency, Chronic
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Fan Fan Hou, M.D.,Ph.D. principal investigator
Renal Division, Nanfang Hospital,Southern Medical 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, Losartan and Benazepril+Losartan in people with Renal Insufficiency, Chronic, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 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: stopped early, as of the sponsor's last update on 5 Apr 2016. 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 China. 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?
The study was stopped early (reason given: Significant differences observed between groups.). Results are not available in the source record.
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?
The proportion of patients with increase in serum potassium ≥6.0 mmol/L. (time frame: Every 4 weeks). 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 5 Apr 2016.