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Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345137
First Posted: June 27, 2006
Last Update Posted: June 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Regional Hospital Holstebro
  Purpose
The study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis.

Condition Intervention Phase
ADPKD Glomerulonephritis Drug: Ng-monomethyl-L-arginine (drug) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Official Title: Phase 1 Study of Systemic Effects of Ng-Monomethyl-L-Arginine on Renal Hemodynamics in Patients With Polycystic Kidney Disease and Chronic Glomerulonephritis

Resource links provided by NLM:


Further study details as provided by Regional Hospital Holstebro:

Estimated Enrollment: 75
Detailed Description:

In a randomized, placebo controlled design, the effects of systemic treatment with monomethyl-L-arginine are studied on:

  1. renal hemodynamics
  2. renal sodium excretion and lithium clearance
  3. blood pressure and heart rate
  4. plasma levels of vasoactive hormones

in patients with adult polycystic kidney disease and chronic glomerulonephrits. The results are compared with a group of healthy control subjects

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy controls

  • Age 20 to 60 years
  • Both men and women
  • Weight below 100 kg
  • Normal clinical examination and laboratory screening
  • Fertile women only if using contraception
  • Informed consent according to the regulations of the local etics committee

Chronic glomerulonephritis

  • Biopsy veryfied chronic glomerulonephritis
  • P-creatinine < 250 µmol/L
  • Weight below 100 kg
  • Age 20 to 60 years
  • Both men and women
  • Informed consent according to the regulations of the local etics committee

Adult polycystic kidney disease (APKD)

  • Diagnosis of APKD by family history and renal ultrasound or renal angiography
  • P-creatinine < 250 µmol/L
  • Weight below 100 kg
  • Age 20 to 60 years
  • Both men and women
  • Informed consent according to the regulations of the local etics committee

Exclusion Criteria:

Healthy controls

  • History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
  • Current medication
  • Drugs or alcohol abuse
  • Pregnancy
  • Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
  • Donation of blood less than 1 month before the experiments

Chronic glomerulonephritis

  • Apart from chronic glomerulonephritis and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
  • Patients with nephrotic syndrome or secondary glomerulonephritis
  • Current medication other than antihypertensive therapy
  • Drugs or alcohol abuse
  • Pregnancy
  • Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances

Adult polycystic kidney disease

  • Apart from APKD and hypertension no history of diseases of the heart and blood vessels, liver and pancreas, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
  • Current medication other than antihypertensive therapy
  • Drugs or alcohol abuse
  • Pregnancy
  • Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00345137


Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Chair: Erling B Pedersen, Professor Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Principal Investigator: Jesper N Bech, MD, Ph.d. Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00345137     History of Changes
Other Study ID Numbers: MED.RES.HOS.1995.02.JNB
First Submitted: June 24, 2006
First Posted: June 27, 2006
Last Update Posted: June 27, 2006
Last Verified: June 2006

Keywords provided by Regional Hospital Holstebro:
Renal hemodynamics
Nitric oxide

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Glomerulonephritis
Chronic Disease
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Nephritis
Disease Attributes
Pathologic Processes
omega-N-Methylarginine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action