PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

The purpose of this study is to determine if the early treatment with a blood pressure medication (an ACE Inhibitor) can prevent or delay the development of kidney disease (microalbuminuria) in patients with Type 1 diabetes who have normal blood pressure and urine albumin levels.

Key facts

Study ID: NCT00729365
Run by: Northwestern University
People needed: 65
Starts: 2008-07-01
Expected to finish: 2010-06-01
Last updated by the study team: 2015-03-17

Who can join

Age: 13 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with type 1 diabetes confirmed by C peptide measurements.
Male and Female subjects of all races will be included in this study.
Subjects age must be between 13 to 50 years
Duration of the disease (from time of diagnosis of diabetes) must be between 5 to 28 years.
Subjects must be normotensive defined as a systolic blood pressure of ≤ 130 mmHg and diastolic of ≤ 85 mmHg in subjects 18 and older and for children (ages 13-17) blood pressure will be in the normal range based on standard tables which takes in to account gender, height and age.
The mean 24 blood pressure must meet the same criteria as the office blood pressures outlined above.
Subject must have normoalbuminuria (UAE < 30 mg/24 hrs)
If subject is a female she must not be breast-feeding, and not of child-bearing potential, defined as post-menopausal for at least 1 year or surgically sterile; if she is of child bearing potential, then she must be practicing one of the following methods of birth control: 1) condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD), 2) contraceptives (oral or parenteral) initiated three months prior to study drug administration, 3) maintain a monogamous relationship with a vasectomized partner, or 4) total abstinence from sexual intercourse.

You may not qualify if…

Type 2 diabetics and other types of diabetics such as those with maturity onset diabetes or the young (MODY) will be excluded on the basis of established clinical criteria.
Subjects who have a history of hypertension or is taking any hypertensive medications.
Females who are pregnant or express a desire to become pregnant during the study. Females who are breast-feeding. Refer to details in inclusion criteria above regarding females.
Subjects who have a history of taking ACE inhibitors within the last six months or have a current indication for ACE inhibitor therapy.
Subjects (18 years of age and over) with a current blood pressure above 130mmHg/85mmHg. Subjects (13-17 years of age) who do not meet the normal range based on the standard tables
Subjects who are currently microalbuminuric i.e. 24hr albumin > 30mg
Subjects who have participated in an interventional clinical trial involving ABPM 6 months prior to this study.
Subjects that have a diagnosis of chronic atrial fibrillation.
Subjects with a lifestyle that would disrupt normal circadian rhythm (i.e. night-shift workers).
Subjects with a current serious co-morbid condition for which life expectancy is <2 years.
Subjects with a history of non-compliance, or psychiatric disturbance that would preclude successful completion of the study.
Inability to give informed consent.

Where it is running

University of Florida — Gainesville, Florida, United States
Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
Rush University Medical Center, Endocrinology Section — Chicago, Illinois, United States
University of Illinois at Chicago — Chicago, Illinois, United States
University of Chicago — Chicago, Illinois, United States
Loyola University Chicago — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.