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Hypertensive Renal DiseasePhase 2/3NCT00582777

African American Study of Kidney Disease and Hypertension ABPM Pilot Study

A Phase 2/3 study testing USUAL - take your BP Meds as you usually do, HS DOSING and ADD On Dosing in people with Hypertensive Renal Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

4. Methods 4a. Overview The study will be conducted in participants in the African-American Study of Kidney Disease (AASK) Cohort study as a randomized three period cross-over trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertensive Renal Disease
What is being tested?
USUAL - take your BP Meds as you usually do, HS DOSING and ADD On Dosing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
16 sitesUnited States
Study dates
Nov 2007to Dec 2008
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant in the AASK Cohort Study
  • Ability and willingness to provide informed consent
  • Completion of a technically adequate ABPM at CO48 AASK cohort study visit.
  • Participants must have had at least 2 visits in the last 12 months of the Cohort Study (July 1 2006 to June 1 2007)
  • The average of last two BPs measured at least one week apart in the Cohort Study must be less than or equal to 140/90 mm Hg. This would exclude a small percentage of the AASK cohort population; however, it would enroll a group of participants with stable BP who should not require adjustments to their antihypertensive medications during the course of this study.
  • Antihypertensive medications at baseline visit: This refers to the participant's antihypertensive regimen at the time of the baseline visit ; the transition period may be used to adjust the participant's antihypertensive regimen to meet these criteria, based on the clinical judgement of the site investigator.

Who cannot join

  • Arm circumference greater than 50 cms.
  • ESRD requiring renal replacement therapy or kidney transplantation
  • Institutionalized participants
  • Shift workers working at night
  • MI or CVA within 3 months of AASK Cohort close out visit
  • Participants with known ejection fraction less than 40%
  • Females known to be pregnant or lactating
  • Participants likely to reach end stage renal disease within the next six weeks, in the judgement of the site investigator

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • University of Michigan

    Ann Arbor, Michigan, 48106

  • Emory University

    Atlanta, Georgia, 30308

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • University of Alabama

    Birmingham, Alabama, 35233

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Chicago

    Chicago, Illinois, 60637

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Ohio State University

    Columbus, Ohio, 43210

  • Univesity of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • University of Florida

    Gainesville, Florida, 32611

  • University of Southern California

    Los Angeles, California, 90033

  • Charles Drew Medical College

    Los Angeles, California, 90059

  • University of Miami

    Miami, Florida, 33101

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Lenox Hill Hospital

    New York, New York, 10021

  • University of California at San Diego

    San Diego, California, 92161

Other trials in United States

About this study

  1. Methods 4a. Overview The study will be conducted in participants in the African-American Study of Kidney Disease (AASK) Cohort study as a randomized three period cross-over trial.

Eighty five percent of AASK cohort participants are currently on an ACE inhibitor or angiotensin receptor blocker; the most commonly used ACE inhibitor is ramipril. The new strategies proposed in this pilot study will remain ramipril-based, to maintain the overall blood pressure control achieved thus far.

Read more

The antihypertensive regimens proposed are as follows:

  • AM dosing of ramipril and other once daily medications in the participants antihypertensive regimen (termed USUAL),
  • Bedtime dosing of ramipril and other once a day medications in the participant's antihypertensive regimen (termed HS-DOSING), and
  • their current antihypertensive regimen plus an additional antihypertensive agent dosed at bed time; the choice of the additional agent will be tailored based on prespecified clinical guidelines (termed ADD-ON DOSING)

The "usual arm" serves as the comparator arm. The "hs dosing" and "add-on dosing" arms test practical strategies that could be tested in a subsequent clinical outcomes trial and that could be implemented in clinical practice. We hypothesize that both arms will reduce nocturnal BP in comparison to "usual dosing". We further hypothesize that the "hs dosing" arm will raise daytime BP somewhat but have no net effect on 24 hour BP and that the "add on dosing" arm will have no effect on daytime BP but lower 24 hour BP.

This pilot study will begin after the last scheduled AASK Cohort study visit. Eligible participants will be treated for 6 weeks on each of 3 antihypertensive regimens. The sequence of the regimens will be random. Each period of the three periods will have 2 visits, one visit at 3 weeks and one visit at 6 weeks. In the last week of each 6-week period, a 24-hour ABPM will be obtained. The primary outcome variable is nocturnal BP; each pair wise difference between the regimens will be calculated.

Being tested
USUAL - take your BP Meds as you usually do, HS DOSING, ADD On Dosing
Keywords
nocturnal blood pressure, chronic renal disease, hypertensive renal disease, African Americans, ABPM
Medical subject headings
Hypertensive Nephropathy, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • USUAL - take your BP Meds as you usually doBehavioural

    The patient's antihypertensive regimen at the baseline visit is the comparison (or control) regimen. All once a day medications will be administered in the morning.

  • HS DOSINGBehavioural

    Take your usual BP meds at bed time

  • ADD On DosingDrug

    Take your usual BP meds but add one more med at bed time.

Study groups in NCT00582777
Study groupRoleWhat they receive
USUALActive comparatorUSUAL treatment - The patient's antihypertensive regimen at the baseline visit is the comparison (or control) regimen. All once a day medications will be administered in the morning.
Receives: Behavioral: USUAL - take your BP Meds as you usually do
HS DosingExperimentalHS DOSING - In this period, the patient's antihypertensive regimen at the baseline visit will be standardized for the once/day medications to be given at bedtime. * For those on monotherapy with a once/day antihypertensive regimen, the time of administration will be changed to bed time. * For those on multi-drug therapy, the time of administration of all once a day antihypertensive drugs will be changed to bed time.
Receives: Behavioral: HS DOSING
ADD-ON DOSINGExperimentalADD-ON DOSING - This regimen will start with the USUAL regimen to which an additional agent will be added at bed time. An additional dose of ramipril, diltiazem, or hydralazine are three possible options for the add on medication. The intent of the ADD ON therapy is to lower nocturnal BP with minimal impact on daytime BP. Thus, agents with < 24 hr duration of action are preferred. The specific choice and dose of add-on therapy (of the three agents) will be up to the site investigator considering the clinical situation of each participant based on the guidelines below.
Receives: Drug: ADD On Dosing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Night Time Blood Pressure

    Measured: Night time blood pressure from APBM at weeks 6, 12, and 18

Secondary outcomes (1)

  1. Blood pressure in the clinic Daytime blood pressure

    Measured: Measured at weeks 6, 12, and 18

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00582777
Sponsor's protocol ID
AASK ABPM Pilot (completed)
Other IDs
7 U01 KD04868
Status last verified
Apr 2012
First submitted
20 Dec 2007
Last updated
16 Apr 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Juraschek SP, Appel LJ, Miller ER 3rd. Metoprolol Increases Uric Acid and Risk of Gout in African Americans With Chronic Kidney Disease Attributed to Hypertension. Am J Hypertens. 2017 Sep 1;30(9):871-875. doi: 10.1093/ajh/hpx113.

    PubMed 28830083

  • Rahman M, Greene T, Phillips RA, Agodoa LY, Bakris GL, Charleston J, Contreras G, Gabbai F, Hiremath L, Jamerson K, Kendrick C, Kusek JW, Lash JP, Lea J, Miller ER 3rd, Rostand S, Toto R, Wang X, Wright JT Jr, Appel LJ. A trial of 2 strategies to reduce nocturnal blood pressure in blacks with chronic kidney disease. Hypertension. 2013 Jan;61(1):82-8. doi: 10.1161/HYPERTENSIONAHA.112.200477. Epub 2012 Nov 19.

    PubMed 23172931

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing USUAL - take your BP Meds as you usually do, HS DOSING and ADD On Dosing in people with Hypertensive Renal Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Night Time Blood Pressure (time frame: Night time blood pressure from APBM at weeks 6, 12, and 18). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00582777, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2012.

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