VA NEPHRON-D: Diabetes iN Nephropathy Study

Stopped early · Phase 3

Conditions studied: Kidney Disease, Nephropathy, Type 2 Diabetes

In brief

Diabetes is the leading cause of end-stage renal disease (ESRD) in the United States. The overall rate of ESRD secondary to diabetes has risen 68% since 1992. Medications that block the renin angiotensin system have been shown to decrease the progression of diabetic nephropathy. The use of an angiotensin receptor blocker (ARB) has been shown to decrease the risk of progression of kidney disease in two studies of individuals with Type 2 diabetes and proteinuria. Despite the use of an ARB, the incidence of renal failure remained high in the treated group in both studies. The combination of an angiotensin converting enzyme inhibitor (ACEI) and ARB can lead to more complete blockade of the renin angiotensin system. In diabetic kidney disease, combination therapy has been shown to decrease proteinuria in short-term studies. Although there are encouraging results for improvement in proteinuria there are no data on progression of kidney disease for the use of combination of ACEI and ARB therapy in patients with diabetes. In addition, there could be an increased risk of serious hyperkalemia in individuals with diabetes who receive combination ACEI and ARB. The investigators therefore propose a randomized double blind multi-center clinical trial to assess the effect of combination of ACEI and ARB in patients with diabetes and proteinuria on progression of kidney disease.

Key facts

Study ID

NCT00555217

Run by

US Department of Veterans Affairs

People needed

1448

Starts

2008-07-01

Expected to finish

2014-10-01

Last updated by the study team

2015-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 2 diabetes
• Albuminuria >300mg/gram creatinine
• Stage 2 or 3 CKD (eGFR 30 to <90 mg/min/1.73m*2 )
• Able to give informed consent
• Telephone contact available

You may not qualify if…

• History of intolerance to ACEI or ARB
• Serum potassium level >5.5 meq/L
• Receiving sodium polystyrene sulfonate (Kayexalate)
• Pregnancy, breast feeding, planning to become pregnant or sexually active and not using birth control
• Renal transplant recipient
• Suspected non-diabetic kidney disease
• Inability to discontinue current use of ACEI/ARB combination
• Current use of Lithium
• Severe (end-stage) comorbid disease
• Prisoner
• Age <18
• Estimated glomerular filtration rate (GFR) <30 or >=90 ml/min/1.73m*m
• HbA1c >10.5%
• Patient refusal
• Participation in a concurrent interventional study
• Blood pressure >180/95
• Unwilling to stop any proscribed medications after enrollment

Where it is running

• Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States
• Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock — Little Rock, Arkansas, United States
• VA Medical Center, Loma Linda — Loma Linda, California, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States
• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
• VA Medical Center, Miami — Miami, Florida, United States
• James A. Haley Veterans Hospital, Tampa — Tampa, Florida, United States
• Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
• Richard Roudebush VA Medical Center, Indianapolis — Indianapolis, Indiana, United States
• VA Medical Center, Iowa City — Iowa City, Iowa, United States
• VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States
• VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
• VA Medical Center, Kansas City MO — Kansas City, Missouri, United States
• VA Medical Center, St Louis — St Louis, Missouri, United States
• VA Medical Center, Omaha — Omaha, Nebraska, United States
• VA New Jersey Health Care System, East Orange — East Orange, New Jersey, United States
• New Mexico VA Health Care System, Albuquerque — Albuquerque, New Mexico, United States
• VA Western New York Healthcare System at Buffalo — Buffalo, New York, United States
• VA Medical Center, Durham — Durham, North Carolina, United States
• VA Medical Center, Cleveland — Cleveland, Ohio, United States
• VA Medical Center, Portland — Portland, Oregon, United States
• VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania, United States
• Ralph H Johnson VA Medical Center, Charleston — Charleston, South Carolina, United States
• WJB Dorn Veterans Hospital, Columbia — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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