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Endothelin Receptor Antagonism in Proteinuric Nephropathy

NCT ID: NCT00722215

Last Updated: 2008-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-12-31

Brief Summary

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The number of people with kidney problems is increasing rapidly, related in part to the increasing prevalence of diabetes. Patients with kidney problems tend to have protein leaking into the urine (proteinuria). Both proteinuria and the kidney disease itself are associated with an increased risk of heart disease. Reducing proteinuria is an important treatment goal in people with kidney problems. Endothelin is a chemical produced both by blood vessels and the kidney. Higher than normal levels of endothelin are thought to contribute to progression of kidney disease and proteinuria. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') we can hopefully reduce both of these. The purpose of the study is to ascertain whether endothelin receptor antagonists improve kidney function and reduce proteinuria more so than other commonly used drugs.

Detailed Description

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Response to ETA Receptor Antagonism/Nifedipine/Placebo Prior to the study visit subjects will be asked to refrain from alcohol for 24 hours. Tea and coffee will not be permitted for at least 12 hours before each visit. Studies will be conducted in a quiet, temperature-controlled room.

On arrival at the Clinical Research Centre on the study day, a brief medical enquiry and examination will confirm the ongoing suitability of the subject for the study. An intravenous cannula will be inserted into the antecubital fossa of each arm. We have developed a basic protocol described fully in our previous studies that allows us to measure systemic haemodynamics by the well validated technique of bioimpedance and renal function by standard para-aminohippurate (PAH; renal blood flow) and inulin (glomerular filtration rate) clearance studies.

Urinary protein excretion will be measured by collecting urine over 30 minute time periods. To ascertain the contribution of renal haemodynamics to any change in protein excretion renal blood flow and glomerular filtration rate will be measured. In addition, blood and urine will also be assayed for sodium, creatinine and osmolality to allow calculation of fractional excretion of sodium and free water clearance.

Systemic haemodynamic monitoring will be performed at 15 minute intervals during drug/placebo administration and at 30 minute intervals outwith these periods.

Conditions

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Chronic Kidney Disease Proteinuria

Keywords

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Endothelin antagonist Chronic kidney disease Proteinuria Cardiovascular disease Blood pressure Arterial stiffness Endothelial function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Placebo control arm of study

Group Type PLACEBO_COMPARATOR

0.9 % saline

Intervention Type DRUG

Single 15ml 0.9% saline infused for 15 mins as placebo control

2

BQ-123 arm of study

Group Type EXPERIMENTAL

BQ-123 (selective endothelin A receptor antagonist)

Intervention Type DRUG

Single dose of BQ-123 given at a dose of 1000 nmol/min for 15 min intravenously.

3

Nifedipine arm of study

Group Type ACTIVE_COMPARATOR

Nifedipine

Intervention Type DRUG

Single dose of nifedipine 10 mg given orally as active control

Interventions

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BQ-123 (selective endothelin A receptor antagonist)

Single dose of BQ-123 given at a dose of 1000 nmol/min for 15 min intravenously.

Intervention Type DRUG

0.9 % saline

Single 15ml 0.9% saline infused for 15 mins as placebo control

Intervention Type DRUG

Nifedipine

Single dose of nifedipine 10 mg given orally as active control

Intervention Type DRUG

Other Intervention Names

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Adalat

Eligibility Criteria

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Inclusion Criteria

* Male or female
* Age 18-70
* Body mass index \<35
* Blood pressure \<160/110 mmHg
* CKD stage 2-5 as per the K/DOQI classification
* Proteinuria in one of the following categories: 0.3-1.5, \>1.5-3.0, and \>3.0-6.0 g/24hrs
* Normal serum albumin

Exclusion Criteria

* Subject is below the age of legal consent, or is mentally or legally incapacitated
* History of multiple and/or severe allergic reactions to drugs (including study drugs), or food
* The subject has donated blood (450 ml) within the last 4 weeks
* Past or present drug or alcohol abuse including intravenous drug abuse at any time
* Participation in another clinical trial within 1 month
* Considered to be at high risk of HIV or hepatitis B
* Pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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British Heart Foundation

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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The University of Edinburgh

Principal Investigators

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Neeraj Dhaun, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

David J Webb, MD

Role: STUDY_DIRECTOR

University of Edinburgh

Locations

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Clinical Research Centre, Western General Hospital

Edinburgh, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PG/05/91

Identifier Type: -

Identifier Source: secondary_id

06/MRE00/12

Identifier Type: -

Identifier Source: secondary_id

2006/WCRC/02

Identifier Type: -

Identifier Source: org_study_id