NCT00722215

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
Last Updated

July 25, 2008

Status Verified

August 1, 2006

Enrollment Period

1.5 years

First QC Date

July 23, 2008

Last Update Submit

July 23, 2008

Conditions

Chronic Kidney DiseaseProteinuria

Keywords

Endothelin antagonistChronic kidney diseaseProteinuriaCardiovascular diseaseBlood pressureArterial stiffnessEndothelial function

Outcome Measures

Primary Outcomes (2)

  • Proteinuria

    Acute change in proteinuria over 4 hour period following BQ-123 dosing

  • Blood pressure

    Acute change in blood pressure over 4 hour period following BQ-123 dosing

Secondary Outcomes (2)

  • Arterial stiffness (as measured by pulse wave velocity)

    Acute change in arterial stiffness over 4 hour period following BQ-123 dosing

  • Endothelial function (as measured by flow-mediated dilatation)

    Acute change in endothelial function over 4 hour period following BQ-123 dosing

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo control arm of study

Drug: 0.9 % saline

2

EXPERIMENTAL

BQ-123 arm of study

Drug: BQ-123 (selective endothelin A receptor antagonist)

3

ACTIVE COMPARATOR

Nifedipine arm of study

Drug: Nifedipine

Interventions

BQ-123 (selective endothelin A receptor antagonist)DRUG

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

2
0.9 % salineDRUG

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

1
NifedipineDRUG

Single dose of nifedipine 10 mg given orally as active control

Also known as: Adalat
3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Centre, Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicProteinuriaCardiovascular Diseases

Interventions

cyclo(Trp-Asp-Pro-Val-Leu)Sodium ChlorideNifedipine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsDihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Neeraj Dhaun, MBChB

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

  • David J Webb, MD

    University of Edinburgh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

May 1, 2006

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

July 25, 2008

Record last verified: 2006-08

Locations

GB(1)