Type 2 Diabetes With NephropathyPhase 4NCT00949351
Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
A Phase 4 study testing Aliskiren 300mg/d in people with Type 2 Diabetes With Nephropathy, run by Lerdsin General Hospital at 1 site in Thailand.
Trial summary
Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes With Nephropathy
- What is being tested?
- Aliskiren 300mg/d
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type2 diabetes patients
- Age <30yrs-70yrs>
- Overt proteinuria (Urinary protein creatinine ratio > 200mg/g 2 times or more during past 6 Mo)
- Scr < 2.5 mg/dL
- HbA1C < 7.5
- Systolic blood pressure > 160 mmHg without antihypertensive drugs or > 140 with antihypertensive drug
- No history of previous cardiovascular event (Stroke, Myocardial infarction, unstable angina, hospitalization, surgical correction PVD or PVD with claudication)
- No hospitalization within 1 yr except for elective surgery
Who cannot join
- Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)
- Non adherence to protocol
- Intolerable to ACEI or ARB during run-in
- Abnormal liver function test at the run-in period
- Rapid declining renal function (SCr increase > 40%) during run-in
- Hyperkalemia (serum K > 5.5 mEq/L at randomization)
- Malignancy detected o
- SBP lower than 110 mmHg (at randomization)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Lerdsin General Hospital
Bangkok, 10500
Krissanapong Manotham, Dr, 662 3539799 ext. 2501, kmanotham@hotmail.com
Tanaporn Ratanasuwan, Dr, tratanas@hotmail.com
About this study
Official title: Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy
Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.
- Conditions
- Type 2 Diabetes With Nephropathy
- Being tested
- Aliskiren 300mg/d
- Keywords
- ACEI, ARB, DN, aliskiren, proteinuria
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren 300mg/dDrug
Also called Rasilez (Thailand)
Aliskiren 300mg/d v.s. placebo for 12wk
| Study group | Role | What they receive |
|---|---|---|
| Aliskiren | Placebo comparator | Not described Receives: Drug: Aliskiren 300mg/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy
Measured: 12 wk after randomization
Secondary outcomes (5)
Reduction of systolic blood pressure
Measured: 12 wk after randomization
Reduction of proteinuria
Measured: 12 wk after randomization
Change in GFR/mo
Measured: 12 wk after randomization
Change of Serum prorenin level compare to baseline
Measured: 12 wk after randomization
Change of Urinary TGFb1 compare to baseline
Measured: 12 wk after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes With NephropathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lerdsin General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949351
- Sponsor's protocol ID
- Lerdsin 36/52
- Status last verified
- Jul 2009
- First submitted
- 29 Jul 2009
- Last updated
- 30 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy
- ClinicalTrials.gov ID
- NCT00949351
- Acronym / sponsor ID
- Lerdsin 36/52
- Conditions
- Type 2 Diabetes With Nephropathy
- Keywords
- ACEI, ARB, DN, aliskiren, proteinuria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lerdsin General HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 30 Jul 2009 (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.
Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aliskiren | Placebo comparator | Drug: Aliskiren 300mg/d |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type2 diabetes patients
- Age <30yrs-70yrs>
- Overt proteinuria (Urinary protein creatinine ratio > 200mg/g 2 times or more during past 6 Mo)
- Scr < 2.5 mg/dL
- HbA1C < 7.5
Key exclusion criteria (8 listed)
- Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)
- Non adherence to protocol
- Intolerable to ACEI or ARB during run-in
- Abnormal liver function test at the run-in period
- Rapid declining renal function (SCr increase > 40%) during run-in
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 |
|---|---|---|
| Aliskiren 300mg/dAlso: Rasilez (Thailand)Aliskiren 300mg/d v.s. placebo for 12wk | Drug | Aliskiren |
Primary outcome
Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy
Time frame: 12 wk after randomization
5 secondary outcomes
Reduction of systolic blood pressure
Time frame: 12 wk after randomization
Reduction of proteinuria
Time frame: 12 wk after randomization
Change in GFR/mo
Time frame: 12 wk after randomization
Change of Serum prorenin level compare to baseline
Time frame: 12 wk after randomization
Change of Urinary TGFb1 compare to baseline
Time frame: 12 wk after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2009.
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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 Phase 4 study testing Aliskiren 300mg/d in people with Type 2 Diabetes With Nephropathy, run by Lerdsin General Hospital at 1 site in Thailand.
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 8 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: status not confirmed, as of the sponsor's last update on 30 Jul 2009. 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 Thailand. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Krissanapong Manotham, Dr (662 3539799 ext. 2501, kmanotham@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy (time frame: 12 wk after randomization). 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 Jul 2009.