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Endothelin Receptor Antagonism in Proteinuric Nephropathy

23. juli 2008 opdateret af: University of Edinburgh

The Systemic & Renal Effects of Endothelin Receptor Antagonism in Proteinuric Nephropathy

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

22

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
    • Scotland
      • Edinburgh, Scotland, Det Forenede Kongerige, EH4 2XU
        • Clinical Research Centre, Western General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 1
Placebo control arm of study
Medicin: 0.9 % saline
Single 15ml 0.9% saline infused for 15 mins as placebo control
Eksperimentel: 2
BQ-123 arm of study
Medicin: BQ-123 (selective endothelin A receptor antagonist)
Single dose of BQ-123 given at a dose of 1000 nmol/min for 15 min intravenously.
Aktiv komparator: 3
Nifedipine arm of study
Medicin: Nifedipine
Single dose of nifedipine 10 mg given orally as active control
Andre navne:
  • Adalat

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proteinuria
Tidsramme: Acute change in proteinuria over 4 hour period following BQ-123 dosing
Acute change in proteinuria over 4 hour period following BQ-123 dosing
Blood pressure
Tidsramme: Acute change in blood pressure over 4 hour period following BQ-123 dosing
Acute change in blood pressure over 4 hour period following BQ-123 dosing

Sekundære resultatmål

Resultatmål
Tidsramme
Arterial stiffness (as measured by pulse wave velocity)
Tidsramme: Acute change in arterial stiffness over 4 hour period following BQ-123 dosing
Acute change in arterial stiffness over 4 hour period following BQ-123 dosing
Endothelial function (as measured by flow-mediated dilatation)
Tidsramme: Acute change in endothelial function over 4 hour period following BQ-123 dosing
Acute change in endothelial function over 4 hour period following BQ-123 dosing

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Edinburgh

Samarbejdspartnere

British Heart Foundation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2006

Primær færdiggørelse (Faktiske)

1. november 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

23. juli 2008

Først indsendt, der opfyldte QC-kriterier

23. juli 2008

Først opslået (Skøn)

25. juli 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. juli 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2008

Sidst verificeret

1. august 2006

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2006/WCRC/02
  • PG/05/91
  • 06/MRE00/12

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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