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CompletedNCT00345137Updated Jun 27, 2006

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

A Phase 1 interventional study of Ng-monomethyl-L-arginine (drug) in ADPKD and Glomerulonephritis, sponsored by Regional Hospital Holstebro. Completed. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-06-27.

Sponsored by Regional Hospital Holstebro · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
20 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • ADPKD
  • Glomerulonephritis

Keywords

  • Renal hemodynamics
  • Nitric oxide
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 75 is close to the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Regional Hospital Holstebro is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
75 participants

Interventions

  • DrugNg-monomethyl-L-arginine (drug)
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00345137
Lead sponsor
Regional Hospital Holstebro
First posted
Jun 27, 2006
Last update
Jun 27, 2006

Study contacts

Erling B Pedersen, Professor
study chair · Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
Jesper N Bech, MD, Ph.d.
principal investigator · Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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