Chronic Kidney DiseasePhase 2NCT00609544
Study of the Safety and Effectiveness of Rilonacept (IL-1 Trap) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia
A Phase 2 study testing Rilonacept in people with Chronic Kidney Disease and Anemia, run by Regeneron Pharmaceuticals at 27 sites in United States.
Trial summary
Anemia of inflammation is a common complication in patients with chronic kidney disease (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of adequate iron stores. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Anemia
- What is being tested?
- Rilonacept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 27 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female greater than 18 years of age
- Chronic Kidney Disease (CKD) not yet requiring renal replacement therapy (pre-dialysis patients)
- Not expected to require dialysis during duration of the study
- Adequate laboratory values
- If on rHuEPO therapy, the dose must be stable
Who cannot join
- Persistent chronic or active infections
- Intravenous (IV) iron administration within 12 weeks prior to the Screening Visit
- Known history of severe uncontrolled hyperparathyroidism
- Prior recipient or scheduled to receive a kidney transplant during the study
- Abnormal laboratory values
- Unstable angina or myocardial infarction within the past 6 months prior to the Screening Visit
Show all 17Show fewer
- Uncontrolled hypertension
- Coronary disease diagnosed in the 3 months prior to the Screening Visit
- Severe Congestive Heart Failure
- History of HIV
- Hepatitis B and/or Hepatitis C
- Abnormal chest radiograph
- A positive intradermal skin tuberculin test
- History or presence of cancer within 5 years of the Screening Visit
- History of alcohol abuse or current intake of 21 or more alcohol-containing drinks per week
- History of drug abuse within the 5 years prior to the Screening Visit
- Lactating females or pregnant females
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Study site
Alexander City, Alabama
Study site
Allentown, Pennsylvania
Study site
Barlett, Tennessee
Study site
Blue Ridge, Georgia
Study site
Cerritos, California
Study site
Clarksville, Tennessee
Study site
Collierville, Tennessee
Study site
Colorado Springs, Colorado
Study site
Crossville, Tennessee
Study site
Falls Church, Virginia
Study site
Harrisburg, Pennsylvania
Study site
Jonesboro, Georgia
Study site
Lauderdale Lakes, Florida
Study site
Long Beach, California
Study site
Los Alampios, California
Study site
Memphis, Tennessee
Study site
Mooresville, North Carolina
Study site
Muscle Shoals, Alabama
Study site
Ogden, Utah
Study site
Orangeburg, South Carolina
Study site
Pembroke Pines, Florida
Study site
Portland, Maine
Study site
Queens, New York
Study site
Shelby, North Carolina
Study site
Sumter, South Carolina
Study site
Tampa, Florida
Study site
Thousand Palms, California
About this study
Official title: A Multi-Center, Double-Blind, Placebo-Controlled Safety and Preliminary Efficacy Study of IL-1 Trap (Rilonacept) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia
Anemia of inflammation is a common complication in patients with chronic kidney disease (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of adequate iron stores. This decreased responsiveness is associated with increased levels of proinflammatory cytokines. Rilonacept is being developed for the treatment of inflammatory disorders.
This is a clinical research study to determine the safety and effectiveness of rilonacept for the treatment of anemia in inflamed patients with CKD who are not yet on dialysis.
- Conditions
- Chronic Kidney Disease, Anemia
- Being tested
- Rilonacept
- Keywords
- Non Dialysis-dependent chronic kidney disease and anemia
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilonaceptDrug
Loading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Rilonacept |
| 2 | Placebo comparator | Not described Receives: Drug: Rilonacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood hemoglobin concentration.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
Why it stopped: Unable to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Investigators
- Gary Swergold, MD, PhD, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609544
- Sponsor's protocol ID
- IL1T-AN-0704
- Status last verified
- Apr 2011
- First submitted
- 10 Dec 2007
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Placebo-Controlled Safety and Preliminary Efficacy Study of IL-1 Trap (Rilonacept) Administered Subcutaneously in Subjects With Non Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) and Anemia
- ClinicalTrials.gov ID
- NCT00609544
- Acronym / sponsor ID
- IL1T-AN-0704
- Conditions
- Chronic Kidney Disease, Anemia
- Keywords
- Non Dialysis-dependent chronic kidney disease and anemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- First posted
- 7 Feb 2008 (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.
Anemia of inflammation is a common complication in patients with chronic kidney disease (CKD). Patients with CKD and anemia of inflammation also exhibit decreased response to erythropoietic agents, even in the presence of adequate iron stores. This decreased responsiveness is associated with increased levels of proinflammatory cytokines. Rilonacept is being developed for the treatment of inflammatory disorders.
This is a clinical research study to determine the safety and effectiveness of rilonacept for the treatment of anemia in inflamed patients with CKD who are not yet on dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rilonacept |
| 2 | Placebo comparator | Drug: Rilonacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female greater than 18 years of age
- Chronic Kidney Disease (CKD) not yet requiring renal replacement therapy (pre-dialysis patients)
- Not expected to require dialysis during duration of the study
- Adequate laboratory values
- If on rHuEPO therapy, the dose must be stable
Key exclusion criteria (17 listed)
- Persistent chronic or active infections
- Intravenous (IV) iron administration within 12 weeks prior to the Screening Visit
- Known history of severe uncontrolled hyperparathyroidism
- Prior recipient or scheduled to receive a kidney transplant during the study
- Abnormal laboratory values
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 |
|---|---|---|
| RilonaceptLoading dose of 320 mg Rilonacept or placebo followed by 160 mg Rilonacept or placebo once a week for 11 weeks | Drug | 1, 2 |
Primary outcome
Change in blood hemoglobin concentration.
Time frame: Baseline to Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
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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.
Gary Swergold, MD, PhD study director
Regeneron Pharmaceuticals
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rilonacept in people with Chronic Kidney Disease and Anemia, run by Regeneron Pharmaceuticals at 27 sites in United States.
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 5 inclusion and 17 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: withdrawn, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in blood hemoglobin concentration. (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2011.