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

NCT00345137 | Completed Phase 1

• 1 other identifier: MED.RES.HOS.1995.02.JNB
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis.

Conditions

ADPKD; Glomerulonephritis

Keywords

Renal hemodynamics; Nitric oxide

Interventions

Ng-monomethyl-L-arginine (drug) DRUG

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Regional Hospital Holstebro: lead

Related Publications (1)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Glomerulonephritis

Interventions

omega-N-Methylarginine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Nephritis

Intervention Hierarchy (Ancestors)

Arginine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Erling B Pedersen, Professor

  Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark

  STUDY CHAIR

• Jesper N Bech, MD, Ph.d.

  Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 24, 2006
• First Posted: June 27, 2006
• Last Updated: June 27, 2006

Record last verified: 2006-06