Angiotensin II Antagonism of TGF-Beta 1

NCT00320970 | Completed

• 1 other identifier: HI831
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Nephropathy; Hypertension

Keywords

TGF-Beta 1; Angiotensin II; Advanced glycation end products

Outcome Measures

Primary Outcomes (5)

• Blood pressure

• Urinary TGF-Beta 1

• Serum angiotensin II

• Urinary albumin

• Urinary carboxymethyllysine

Interventions

Candesartan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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• Patients unable to be withdrawn for 2 weeks from AT-II antagonist or ACE- inhibitor therapy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

Sponsors & Collaborators

• Providence Health & Services: lead
• AstraZeneca: collaborator

Study Sites (1)

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Diabetic Nephropathies; Hypertension; Camurati-Engelmann Syndrome

Interventions

candesartan

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Katherine R. Tuttle, MD,FASN,FACP

  Providence Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: August 1, 2002
• Study Completion: September 1, 2004
• Last Updated: August 2, 2007

Record last verified: 2006-03

Locations

US (1)