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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by Lerdsin General Hospital. Recruitment status was Not yet recruiting

First Received on July 29, 2009. No Changes Posted

Sponsor:	Lerdsin General Hospital
Information provided by:	Lerdsin General Hospital
ClinicalTrials.gov Identifier:	NCT00949351

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes With Nephropathy	Drug: Aliskiren 300mg/d	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Diabetic Kidney Problems

Drug Information available for: Aliskiren

U.S. FDA Resources

Further study details as provided by Lerdsin General Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Reduction of systolic blood pressure [ Time Frame: 12 wk after randomization ] [ Designated as safety issue: No ]
Reduction of proteinuria [ Time Frame: 12 wk after randomization ] [ Designated as safety issue: No ]
Change in GFR/mo [ Time Frame: 12 wk after randomization ] [ Designated as safety issue: Yes ]
Change of Serum prorenin level compare to baseline [ Time Frame: 12 wk after randomization ] [ Designated as safety issue: No ]
Change of Urinary TGFb1 compare to baseline [ Time Frame: 12 wk after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Aliskiren	Drug: Aliskiren 300mg/d Aliskiren 300mg/d v.s. placebo for 12wk Other Name: Rasilez (Thailand)

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949351

Contacts

Contact: Krissanapong Manotham, Dr	662 3539799 ext 2501	kmanotham@hotmail.com
Contact: Tanaporn Ratanasuwan, Dr	662 3539799 ext 9722	tratanas@hotmail.com

Locations

Thailand
Lerdsin General Hospital	Not yet recruiting
Bangkok, Thailand, 10500
Contact: Krissanapong Manotham, Dr 662 3539799 ext 2501 kmanotham@hotmail.com
Contact: Tanaporn Ratanasuwan, Dr tratanas@hotmail.com
Principal Investigator: Krissanapong Manotham, Dr

Sponsors and Collaborators

Lerdsin General Hospital

More Information

No publications provided

Responsible Party:	Division of Nephrology, Department of Medicine, Lerdsin General Hospital
ClinicalTrials.gov Identifier:	NCT00949351 History of Changes
Other Study ID Numbers:	Lerdsin 36/52
Study First Received:	July 29, 2009
Last Updated:	July 29, 2009
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by Lerdsin General Hospital:

ACEI, ARB, DN, aliskiren, proteinuria

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Enzyme Inhibitors
Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012