ADPKDPhase 1NCT00345137
Effects of Systemic NO-Inhibition on Renal Hemodynamics in Patiens With Polycystic Kidney Disease and Chronic Glomerulonephritis
A Phase 1 study testing Ng-monomethyl-L-arginine (drug) in people with ADPKD and Glomerulonephritis, run by Regional Hospital Holstebro.
Trial summary
The study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- ADPKD, Glomerulonephritis
- What is being tested?
- Ng-monomethyl-L-arginine (drug)
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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
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:
- renal hemodynamics
- renal sodium excretion and lithium clearance
- blood pressure and heart rate
- 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
- Conditions
- ADPKD, Glomerulonephritis
- Being tested
- Ng-monomethyl-L-arginine (drug)
- Keywords
- Renal hemodynamics, Nitric oxide
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Glomerulonephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ng-monomethyl-L-arginine (drug)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADPKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B Pedersen, Professor, Study chair, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, DenmarkJesper N Bech, MD, Ph.d., Principal investigator, Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345137
- Sponsor's protocol ID
- MED.RES.HOS.1995.02.JNB
- Status last verified
- Jun 2006
- First submitted
- 24 Jun 2006
- Last updated
- 27 Jun 2006
- Results posted
- No
Publications
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.
PubMed 39356039
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00345137
- Acronym / sponsor ID
- MED.RES.HOS.1995.02.JNB
- Conditions
- ADPKD, Glomerulonephritis
- Keywords
- Renal hemodynamics, Nitric oxide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study tests the hypothesis that systemic and renal nitric oxide availability is changed in polycystic kidney disease and chronic glomerulonephritis.
Detailed description
In a randomized, placebo controlled design, the effects of systemic treatment with monomethyl-L-arginine are studied on:
- renal hemodynamics
- renal sodium excretion and lithium clearance
- blood pressure and heart rate
- 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
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Healthy controls
- Age 20 to 60 years
- Both men and women
- Weight below 100 kg
- Normal clinical examination and laboratory screening
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ng-monomethyl-L-arginine (drug) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2006.
- Derived from this study: PubMed 39356039St 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ng-monomethyl-L-arginine (drug) in people with ADPKD and Glomerulonephritis, run by Regional Hospital Holstebro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2006.