Angiotensin II Antagonism of TGF-Beta 1

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00320970
First received: April 28, 2006
Last updated: August 1, 2007
Last verified: March 2006
  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: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Angiotensin II Antagonism of TGF-Beta 1: A Candesartan Dose - TGF-Beta 1 Response Relationship Study

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 & Services
AstraZeneca
Investigators
Principal Investigator: Katherine R. Tuttle, MD,FASN,FACP Providence Medical Research Center
  More Information

No publications provided

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

Keywords provided by Providence Health & Services:
TGF-Beta 1
Angiotensin II
Advanced glycation end products

Additional relevant MeSH terms:
Diabetic Nephropathies
Hypertension
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Angiotensin II
Candesartan
Candesartan cilexetil
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014