Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy

Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00949351

Enrollment

Registered

2009-07-30

Start date

2009-09-30

Completion date

2010-09-30

Last updated

2009-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes With Nephropathy

Keywords

ACEI, ARB, DN, aliskiren, proteinuria

Brief 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. 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.

Interventions

DRUGAliskiren 300mg/d

Aliskiren 300mg/d v.s. placebo for 12wk

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame
Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy	12 wk after randomization

Secondary

Measure	Time frame
Reduction of systolic blood pressure	12 wk after randomization
Reduction of proteinuria	12 wk after randomization
Change in GFR/mo	12 wk after randomization
Change of Serum prorenin level compare to baseline	12 wk after randomization
Change of Urinary TGFb1 compare to baseline	12 wk after randomization

Countries

Thailand

Contacts

Primary ContactKrissanapong Manotham, Dr

kmanotham@hotmail.com662 3539799

Backup ContactTanaporn Ratanasuwan, Dr

tratanas@hotmail.com662 3539799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026