NCT00949351

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

July 30, 2009

Status Verified

July 1, 2009

Enrollment Period

10 months

First QC Date

July 29, 2009

Last Update Submit

July 29, 2009

Conditions

Type 2 Diabetes With Nephropathy

Keywords

ACEI, ARB, DN, aliskiren, proteinuria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

Aliskiren

PLACEBO COMPARATOR
Drug: Aliskiren 300mg/d

Interventions

Aliskiren 300mg/dDRUG

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

Also known as: Rasilez (Thailand)
Aliskiren

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lerdsin General Hospital

Bangkok, 10500, Thailand

Location

MeSH Terms

Conditions

Proteinuria

Interventions

aliskirenTacrine

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoacridinesAcridinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Krissanapong Manotham, Dr

CONTACT

662 3539799kmanotham@hotmail.com

Tanaporn Ratanasuwan, Dr

CONTACT

662 3539799tratanas@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

July 30, 2009

Record last verified: 2009-07

Locations

TH(1)