HypoalbuminemiaPhase 3ICMNCT00529633
The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
A Phase 3 study testing Thalidomide and Sugar pill in people with Hypoalbuminemia, run by George A. Kaysen, M.D. at 1 site in United States.
Trial summary
Both malnutrition and inflammation are associated with death in dialysis patients and also with cardiovascular disease. The researchers are testing the idea that inflammation causes malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out whether that will increase blood tests that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoalbuminemia
- What is being tested?
- Thalidomide and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- End stage renal disease (ESRD) patients on hemodialysis for at least 3 months.
- Serum C reactive protein level of ≥ 0.8 mg/dl.
- Serum albumin < 3.8 g/dl (BCG).
- Signing a written informed consent form.
- Willingness and ability to comply with the FDA-mandated S.T.E.P.S ® program.
- Age > 18 years.
Who cannot join
- Pregnant and/ or lactating female.
- Active infection within the previous 8 weeks requiring administration of antibiotics.
- Patients receiving systemic immunosuppressive therapy.
- Patients with HIV.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10003
About this study
Official title: Phase 3 Study: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
Both malnutrition and inflammation are associated with death in dialysis patients and also with cardiovascular disease. The researchers are testing the idea that inflammation causes malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out whether that will increase blood tests that are associated with malnutrition. The researchers will give hemodialysis patients who have both inflammation and malnutrition either thalidomide or a placebo and compare the effects of treatment on the levels of two proteins in the blood, albumin and prealbumin, that are normally reduced in malnourished patients. Patients who have a serum albumin concentration < 3.8 g/dl will be asked to sign consent to have blood drawn prior to dialysis for measurement of CRP (C-reactive protein). Those with CRP values ≥ 0.8 mg/dl will have a second measurement of CRP performed within 2 weeks. Those with two consecutive values of CRP ≥ 0.8 mg/dl will be eligible for enrollment
Read the detailed description
4.1 Pre-assignment measurements will include:
- Patient is eligible for enrollment.
- Complete physical examination.
- Blood draw at initiation of hemodialysis session
- Instruction on birth control methods required.
- Subjects who are non-compliant with regard to medication compliance range or birth control requirements as outlined in the S.T.E.P.S.® program will be immediately discontinued from the study
4.2 Detailed description of treatment: Patients who completed the first 4 weeks will be randomized into Treatment group. A total of 24 subjects will be studied; 12 will receive no drug and 12 will receive thalidomide. Subjects randomized to "Active" Treatment arm will receive Placebo (no-drug/sugar pill) ,or thalidomide 100 mg (two 50 mg active capsules) to take at bedtime. Weekly, Subjects will have blood drawn; will undergo a capsule count to establish a compliance range of > 85%; will have physical exam with special attention to skin and evaluation of peripheral nervous system for a change in or appearance of sensory neuropathy.
If somnolence is tolerable (subjects do not have residual somnolence in the morning) the dose will be increased to 200 mg (4 capsules).
Patients who completed 24 weeks of study will have final evaluation at week 28.
- Conditions
- Hypoalbuminemia
- Being tested
- Thalidomide, Sugar pill
- Keywords
- Inflammation, albumin
- Medical subject headings
- Hypoalbuminemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
Thalidomide by mouth at night for a total of 24 weeks
Sugar pillOther
Also called Placebo (no drug)
Placebo by mouth at night for a total of 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Thalidomide | Active comparator | 1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months
2. Serum C reactive protein level of ≥ 0.8 mg/dl
3. Serum albumin < 3.8 g/dl (BCG)
4. Patients will receive 100mg Thalidomide for a period of 4 weeks; if somnolence tolerated, dosage is increased to 200mg nightly for a period of 20 more weeks -- to total of 24 weeks on Thalidomide. Receives: Drug: Thalidomide |
| No Drug | Placebo comparator | 1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months
2. Serum C reactive protein level of ≥ 0.8 mg/dl
3. Serum albumin < 3.8 g/dl (BCG)
4. Patients will receive Placebo (Sugar pill) for a period of 24 weeks. Receives: Other: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Serum Albumin
Serum albumin in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety
Measured: 28 weeks total
Difference in Serum CRP
Serum CRP in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety
Measured: 28 weeks total
Difference in Serum Prealbumin
Serum Prealbumin in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety
Measured: 28 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2008
- Study completionDec 2009
Why it stopped: Low enrollment -- We could not recruit patients willing to be enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypoalbuminemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- George A. Kaysen, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Medical Center
- Responsible party
- Sponsor-investigator, George A. Kaysen, M.D., University of California, Davis
- Investigators
- George A Kaysen, MD Ph.D, Principal investigator, University of California, DavisJames F. Winchester, MD, Study director, Beth Israel Medicial Center New York New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529633
- Sponsor's protocol ID
- 200614929
- Acronym
- ICM
- Status last verified
- Mar 2018
- First submitted
- 12 Sep 2007
- Last updated
- 2 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study: The Effect of Thalidomide in Suppression of the Systemic Inflammatory Response Syndrome in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00529633
- Acronym / sponsor ID
- ICM / 200614929
- Conditions
- Hypoalbuminemia
- Keywords
- Inflammation, albumin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment -- We could not recruit patients willing to be enrolled
- Enrolment
- 16 participants (actual)
- Lead sponsor
- George A. Kaysen, M.D.University, hospital or other
- Collaborators
- Beth Israel Medical Center
- Study start
- Sep 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Posted 28 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Both malnutrition and inflammation are associated with death in dialysis patients and also with cardiovascular disease. The researchers are testing the idea that inflammation causes malnutrition by using a drug to suppress inflammation in hemodialysis patients to find out whether that will increase blood tests that are associated with malnutrition. The researchers will give hemodialysis patients who have both inflammation and malnutrition either thalidomide or a placebo and compare the effects of treatment on the levels of two proteins in the blood, albumin and prealbumin, that are normally reduced in malnourished patients. Patients who have a serum albumin concentration < 3.8 g/dl will be asked to sign consent to have blood drawn prior to dialysis for measurement of CRP (C-reactive protein). Those with CRP values ≥ 0.8 mg/dl will have a second measurement of CRP performed within 2 weeks. Those with two consecutive values of CRP ≥ 0.8 mg/dl will be eligible for enrollment
Detailed description
4.1 Pre-assignment measurements will include:
- Patient is eligible for enrollment.
- Complete physical examination.
- Blood draw at initiation of hemodialysis session
- Instruction on birth control methods required.
- Subjects who are non-compliant with regard to medication compliance range or birth control requirements as outlined in the S.T.E.P.S.® program will be immediately discontinued from the study
4.2 Detailed description of treatment: Patients who completed the first 4 weeks will be randomized into Treatment group. A total of 24 subjects will be studied; 12 will receive no drug and 12 will receive thalidomide. Subjects randomized to "Active" Treatment arm will receive Placebo (no-drug/sugar pill) ,or thalidomide 100 mg (two 50 mg active capsules) to take at bedtime. Weekly, Subjects will have blood drawn; will undergo a capsule count to establish a compliance range of > 85%; will have physical exam with special attention to skin and evaluation of peripheral nervous system for a change in or appearance of sensory neuropathy.
If somnolence is tolerable (subjects do not have residual somnolence in the morning) the dose will be increased to 200 mg (4 capsules).
Patients who completed 24 weeks of study will have final evaluation at week 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thalidomide | Active comparator | Drug: Thalidomide1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months 2. Serum C reactive protein level of ≥ 0.8 mg/dl 3. Serum albumin < 3.8 g/dl (BCG) 4. Patients will receive 100mg Thalidomide for a period of 4 weeks; if somnolence tolerated, dosage is increased to 200mg nightly for a period of 20 more weeks -- to total of 24 weeks on Thalidomide. |
| No Drug | Placebo comparator | Other: Sugar pill1. 12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months 2. Serum C reactive protein level of ≥ 0.8 mg/dl 3. Serum albumin < 3.8 g/dl (BCG) 4. Patients will receive Placebo (Sugar pill) for a period of 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- End stage renal disease (ESRD) patients on hemodialysis for at least 3 months.
- Serum C reactive protein level of ≥ 0.8 mg/dl.
- Serum albumin < 3.8 g/dl (BCG).
- Signing a written informed consent form.
- Willingness and ability to comply with the FDA-mandated S.T.E.P.S ® program.
Key exclusion criteria (4 listed)
- Pregnant and/ or lactating female.
- Active infection within the previous 8 weeks requiring administration of antibiotics.
- Patients receiving systemic immunosuppressive therapy.
- Patients with HIV.
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 |
|---|---|---|
| ThalidomideThalidomide by mouth at night for a total of 24 weeks | Drug | Thalidomide |
| Sugar pillAlso: Placebo (no drug)Placebo by mouth at night for a total of 24 weeks | Other | No Drug |
Primary outcome
Difference in Serum Albumin
Time frame: 28 weeks total
Serum albumin in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety
Difference in Serum CRP
Time frame: 28 weeks total
Serum CRP in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety
Difference in Serum Prealbumin
Time frame: 28 weeks total
Serum Prealbumin in treated patient and control ("no drug") patients were tabulated once weekly for week #1-4 , then once every 4 weeks thereafter at week# 8, 12, 16, 20, 24 to see changes of health status. Final data collected at week 28 -- to ensure patient safety
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
George A Kaysen, MD Ph.D principal investigator
University of California, Davis
James F. Winchester, MD study director
Beth Israel Medicial Center New York New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thalidomide and Sugar pill in people with Hypoalbuminemia, run by George A. Kaysen, M.D. at 1 site 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 6 inclusion and 4 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 2 Apr 2018. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Serum Albumin (time frame: 28 weeks total). The study lists 3 primary outcomes in all. 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 2 Apr 2018.