Angiotensin II Antagonism of TGF-Beta 1 - Full Text View

Sponsor:	Providence Health Care
Collaborator:	AstraZeneca
Information provided by:	Providence Health Care
ClinicalTrials.gov Identifier:	NCT00320970

Purpose

Diabetic nephropathy is a frequent microvascular complication that occurs in approximately 40% of patients with either type 1 or type 2 diabetes. The most common cause of end-stage renal disease (ESRD) in the United States and in the developed world is diabetic nephropathy. Currently, more than half the United States ESRD population has diabetes. More effective therapies to prevent and treat diabetic nephropathy are urgently needed. One way to increase therapeutic effectiveness is to refine treatment targets based on improved understanding of how treatments modulate disease processes. The purpose of this study is to determine whether a treatment for diabetic nephropathy, the angiotensin receptor blocker candesartan, modifies mediators of kidney injury independent of blood pressure and the relationships to drug dose.

Condition	Intervention
Diabetic Nephropathy Hypertension	Drug: Candesartan

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Angiotensin II Antagonism of TGF-Beta 1: A Candesartan Dose - TGF-Beta 1 Response Relationship Study

Resource links provided by NLM:

Genetics Home Reference related topics: Camurati-Engelmann disease

MedlinePlus related topics: Diabetes Diabetic Kidney Problems High Blood Pressure

Drug Information available for: Angiotensin II CV 11974 Candesartan cilexetil Angiotensin II, ile(5)-

U.S. FDA Resources

Further study details as provided by Providence Health Care:

Primary Outcome Measures:

Blood pressure
Urinary TGF-Beta 1
Serum angiotensin II
Urinary albumin
Urinary carboxymethyllysine

Estimated Enrollment:	36
Study Start Date:	August 2002
Estimated Study Completion Date:	September 2004

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Type 2 diabetes
Nephropathy (proteinuria >500 mg/day)
Chronic Hypertension (as determined by current antihypertensive therapy and/or an average of diastolic blood pressure greater than 90 mmHg or greater or systolic blood pressure of 140 mmHg confirmed on at least two subsequent visits over one week or more).

Exclusion Criteria:

Conditions associated with elevated TGF-Beta (e.g. rheumatoid arthritis, cancer, etc.).
Conditions associated with alterations in serum levels of PIP and/or CITP (liver cirrhosis, osteoporosis, hyperthyroidism, multiple myeloma, osteolytic metastases, and systemic glucocorticoid treatment
History of Stage III hypertension (diastolic BP > 110 mmHg or systolic BP > 180 mmHg) or a history of hypertensive urgency or emergency.
NYHA Class III or IV heart failure
Calculated creatinine clearance of less than 30 ml/min or serum creatinine > 3 mg/dL
HbA1c > 10%
Patients unable to be withdrawn for 2 weeks from AT-II antagonist or ACE- inhibitor therapy
Blood Pressure <140/90 is unachievable in the absence of an AT-II antagonist or ACE-inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320970

Locations

United States, Washington
Providence Medical Research Center
Spokane, Washington, United States, 99204

Sponsors and Collaborators

Providence Health Care

AstraZeneca

Investigators

Principal Investigator:

Katherine R. Tuttle, MD,FASN,FACP

Providence Medical Research Center

More Information

Additional Information:

Click here for more information regarding Providence Medical Research Center This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	HI831
Study First Received:	April 28, 2006
Last Updated:	August 1, 2007
ClinicalTrials.gov Identifier:	NCT00320970 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Providence Health Care:

TGF-Beta 1
Angiotensin II
Advanced glycation end products

Additional relevant MeSH terms:

Diabetic Nephropathies
Molecular Mechanisms of Pharmacological Action
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers

Candesartan cilexetil
Urologic Diseases
Therapeutic Uses
Candesartan
Vasoconstrictor Agents
Cardiovascular Diseases
Kidney Diseases
Diabetes Complications
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010