Chronic Kidney FailureNCT00399256
Improved Estimation of GFR by Cystatin C in Preventing Contrast Induced Nephropathy by NAC or Zn
A study testing Acetylcysteine and Zinc in people with Chronic Kidney Failure, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
Trial summary
Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological prophylaxis (e.g. N-acetylcysteine; NAC) is controversially discussed. So far, in all interventional studies assessment of kidney function was based on measurements of serum creatinine although this surrogate biomarker has… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Failure
- What is being tested?
- Acetylcysteine and Zinc
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2004to Mar 2006
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older than 18 years of age,
- serum creatinine > 1.2 mg/dl or a creatinine clearance < 50 ml/min (measured by a 12 or 24 hour urine collection).
Who cannot join
- acute inflammatory disease,
- medication with NSAID or metformin until 3 days before entering study,
- abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc
Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological prophylaxis (e.g. N-acetylcysteine; NAC) is controversially discussed. So far, in all interventional studies assessment of kidney function was based on measurements of serum creatinine although this surrogate biomarker has several limitations. We investigated the antioxidants NAC and zinc (Zn) for the prevention of CIN by monitoring concomitantly serum levels of creatinine and cystatin C.
Read the detailed description
In a prospective, placebo-controlled, double blind trial patients with moderate impaired kidney function receiving hypoosmolar, nonionic contrast medium were randomly assigned to an oral treatment for 2 days with 1.2g/day of NAC (n=19), for 1 day with 60mg/day of Zn (n=18) or placebo (n=17). All patients were periprocedural hydrated with 1ml/kg/h of 0.45% saline for 24h. At baseline (before hydration), prior to exposure of CM as well as 2 and 6 days after CM serum levels of creatinine and cystatin C have been measured.
- Conditions
- Chronic Kidney Failure
- Being tested
- Acetylcysteine, Zinc
- Keywords
- contrast-induced nephropathy, Acetylcysteine, Zinc, Cystatin C, Creatinine
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcysteineDrug
ZincDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute renal failure
Secondary outcomes (3)
Rise in creatinine of > 0.5 mg/dl
Rise in creatinine > 25%
Significant rise in serum cystatin C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startMar 2004
- Study completionMar 2006
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 Chronic Kidney FailureStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)
- Sponsor type
- University, hospital or other
- Investigators
- Dominik M Alscher, MD, Principal investigator, Robert-Bosch-Hospital, Stuttgart, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399256
- Sponsor's protocol ID
- IKP201
- Status last verified
- Jan 2007
- First submitted
- 13 Nov 2006
- Last updated
- 1 Feb 2007
- Results posted
- No
Publications
Schanz M, Schaaf L, Dippon J, Biegger D, Fritz P, Alscher MD, Kimmel M. Renal effects of metallothionein induction by zinc in vitro and in vivo. BMC Nephrol. 2017 Mar 16;18(1):91. doi: 10.1186/s12882-017-0503-z.
PubMed 28302075
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Estimation of Glomerular Filtration Rate by Serum Cystatin C in Preventing Contrast Induced Nephropathy by N-Acetylcysteine or Zinc
- ClinicalTrials.gov ID
- NCT00399256
- Acronym / sponsor ID
- IKP201
- Conditions
- Chronic Kidney Failure
- Keywords
- contrast-induced nephropathy, Acetylcysteine, Zinc, Cystatin C, Creatinine
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)University, hospital or other
- Study start
- Mar 2004
- Study completion
- Mar 2006
- First posted
- 14 Nov 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.
Background Prevention of contrast media (CM) induced nephropathy (CIN) by pharmacological prophylaxis (e.g. N-acetylcysteine; NAC) is controversially discussed. So far, in all interventional studies assessment of kidney function was based on measurements of serum creatinine although this surrogate biomarker has several limitations. We investigated the antioxidants NAC and zinc (Zn) for the prevention of CIN by monitoring concomitantly serum levels of creatinine and cystatin C.
Detailed description
In a prospective, placebo-controlled, double blind trial patients with moderate impaired kidney function receiving hypoosmolar, nonionic contrast medium were randomly assigned to an oral treatment for 2 days with 1.2g/day of NAC (n=19), for 1 day with 60mg/day of Zn (n=18) or placebo (n=17). All patients were periprocedural hydrated with 1ml/kg/h of 0.45% saline for 24h. At baseline (before hydration), prior to exposure of CM as well as 2 and 6 days after CM serum levels of creatinine and cystatin C have been measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- older than 18 years of age,
- serum creatinine > 1.2 mg/dl or a creatinine clearance < 50 ml/min (measured by a 12 or 24 hour urine collection).
Key exclusion criteria (3 listed)
- acute inflammatory disease,
- medication with NSAID or metformin until 3 days before entering study,
- abnormal findings in physical examinations, e.g. signs of dehydration or decompensated heart failure.
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 |
|---|---|---|
| Acetylcysteine | Drug | – |
| Zinc | Drug | – |
Primary outcome
Incidence of acute renal failure
3 secondary outcomes
Rise in creatinine of > 0.5 mg/dl
Rise in creatinine > 25%
Significant rise in serum cystatin C)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2007.
- Derived from this study: PubMed 28302075Schanz M, Schaaf L, Dippon J, Biegger D, Fritz P, Alscher MD, Kimmel M. Renal effects of metallothionein induction by zinc in vitro and in vivo. BMC Nephrol. 2017 Mar 16;18(1):91. doi: 10.1186/s12882-017-0503-z.
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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.
Dominik M Alscher, MD principal investigator
Robert-Bosch-Hospital, Stuttgart, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetylcysteine and Zinc in people with Chronic Kidney Failure, run by Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF) at 1 site in Germany.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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.
What does the primary outcome measure?
Incidence of acute renal failure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00399256, 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 1 Feb 2007.