Endothelin Receptor Antagonism in Proteinuric Nephropathy
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ClinicalTrials.gov Identifier: NCT00722215 |
Recruitment Status :
Completed
First Posted : July 25, 2008
Last Update Posted : July 25, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease Proteinuria | Drug: BQ-123 (selective endothelin A receptor antagonist) Drug: 0.9 % saline Drug: Nifedipine | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | The Systemic & Renal Effects of Endothelin Receptor Antagonism in Proteinuric Nephropathy |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
Placebo control arm of study
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Drug: 0.9 % saline
Single 15ml 0.9% saline infused for 15 mins as placebo control |
Experimental: 2
BQ-123 arm of study
|
Drug: BQ-123 (selective endothelin A receptor antagonist)
Single dose of BQ-123 given at a dose of 1000 nmol/min for 15 min intravenously. |
Active Comparator: 3
Nifedipine arm of study
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Drug: Nifedipine
Single dose of nifedipine 10 mg given orally as active control
Other Name: Adalat |
- Proteinuria [ Time Frame: Acute change in proteinuria over 4 hour period following BQ-123 dosing ]
- Blood pressure [ Time Frame: Acute change in blood pressure over 4 hour period following BQ-123 dosing ]
- Arterial stiffness (as measured by pulse wave velocity) [ Time Frame: Acute change in arterial stiffness over 4 hour period following BQ-123 dosing ]
- Endothelial function (as measured by flow-mediated dilatation) [ Time Frame: Acute change in endothelial function over 4 hour period following BQ-123 dosing ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722215
United Kingdom | |
Clinical Research Centre, Western General Hospital | |
Edinburgh, Scotland, United Kingdom, EH4 2XU |
Principal Investigator: | Neeraj Dhaun, MBChB | The University of Edinburgh | |
Study Director: | David J Webb, MD | The University of Edinburgh |
Responsible Party: | Dr Neeraj Dhaun, The University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT00722215 |
Other Study ID Numbers: |
2006/WCRC/02 PG/05/91 06/MRE00/12 |
First Posted: | July 25, 2008 Key Record Dates |
Last Update Posted: | July 25, 2008 |
Last Verified: | August 2006 |
Endothelin antagonist Chronic kidney disease Proteinuria Cardiovascular disease |
Blood pressure Arterial stiffness Endothelial function |
Kidney Diseases Renal Insufficiency, Chronic Proteinuria Urologic Diseases Renal Insufficiency Urination Disorders Urological Manifestations Nifedipine Endothelin A Receptor Antagonists |
Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents Tocolytic Agents Reproductive Control Agents Endothelin Receptor Antagonists |