Dialysis AmyloidosisNCT02952144
Post Approval Study of Lixelle for the Treament of Dialysis-Related Amyloidosis
A study testing Lixelle® treatment in people with Dialysis Amyloidosis, run by Kaneka Medical America LLC at 1 site in United States.
Trial summary
Dialysis-related amyloidosis (DRA) is a serious complication of long-term hemodialysis (HD). Its pathogenic mechanism involves accumulation of β2-microglobulin (β2M) in the blood. β2M is produced by most cells in the body and is metabolized in the kidney in healthy individuals. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dialysis Amyloidosis
- What is being tested?
- Lixelle® treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to Oct 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients receiving thrice-weekly HD and diagnosed as DRA by one or more of the following 1 to 4 will be included.
- Biopsy of any tissue, showing Congo-red positive amyloid fibrils and immunohistochemical stains consistent with β2M
- Shoulder ultrasonography showing rotator cuffs greater than 8 mm in thickness, and /or echogenic pads between muscle groups of the rotator cuff
- Two or more diagnoses of the following (1) to (5) (1) Polyarthralgia (2) Carpal tunnel syndrome (3) Trigger finger (4) Dialysis-associated spondylosis ((i) or (ii)) (i) Destructive spondyloarthropathy (DSA) (ii) Spinal stenosis (5) Bone cysts (Bone cysts considered to be caused by other diseases such as osteoarthritis, aneurysmal bone cysts and unicameral bone cysts should be excluded.)
- Biopsy of any tissue, showing Congo-red positive amyloid fibrils, and one diagnosis or surgical history of criterion 3- (1) to (5)
Who cannot join
- Patient who meets any of the following 1 to 7 will be excluded from the study.
- Patient diagnosed with rheumatoid arthritis
- Patient diagnosed with osteoporosis
- Patient diagnosed with osteoarthritis
- Patient planning to receive renal transplantation during the study
- Patient for whom adequate anticoagulation cannot be achieved
Show all 9Show fewer
- Patient for whom extracorporeal circulation therapy is contraindicated, such as those with severe cardiac insufficiency, acute myocardial infarction, severe cardiac arrhythmia, acute seizure disorder, or severe uncontrolled hypertension or hypotension
- Patient planning to become pregnant, pregnant, or breast-feeding
- Patient unable to understand or answer the questionnaires even with a proper assistance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Dialysis-Related Amyloidosis Using Lixelle® β2-microglobulin Apheresis Column
Dialysis-related amyloidosis (DRA) is a serious complication of long-term hemodialysis (HD). Its pathogenic mechanism involves accumulation of β2-microglobulin (β2M) in the blood. β2M is produced by most cells in the body and is metabolized in the kidney in healthy individuals. However, in HD patients with renal dysfunction, β2M which is not removed entirely by HD accumulates excessively in the blood. Then it forms amyloid fibrils that are deposited in bones, joints, and soft tissues. The fibrils are further modified by advanced glycation end products (AGE), inducing local macrophage infiltration and production of cytokines leading to chronic inflammation and activation of osteoclasts. Consequently, severe complications with various symptoms are developed, which are collectively referred to as DRA.
Lixelle® is a whole-blood β2M apheresis column developed to adsorb and eliminate β2M selectively from the blood of DRA patients. The treatment is performed with Lixelle® connected upstream of the dialyzer in series on a HD circuit in every session. The Lixelle® column contains porous cellulose beads with covalently linked hexadecyl alkyl chain ligands, which selectively adsorb β2M, via a molecular sieving effect because of its porous structure and hydrophobic interaction with ligands. Lixelle® has been used to relieve symptoms and prevent the progression of DRA in Japan since 1996, when health insurance coverage and reimbursement for the treatment were approved by Japanese Ministry of Health, Labor, and Welfare. Improvement of the activities of daily living (ADL) and remission of arthralgia by Lixelle® treatment has been shown in several clinical studies.
Read the detailed description
In a post-market study on Lixelle® conducted between 1994 and 1997 in Japan, all adverse events in 183 patients (13, 476 treatments) at 58 centers were collected. The most frequent adverse events were temporary hypotension and anemia, which are common in dialysis or any extracorporeal therapy. Since the maximum blood flow rate for Lixelle® is less than the average blood flow rate for the conventional HD in the USA, Lixelle®- treatment requires a longer treatment time to achieve the same Kt/V urea as the conventional HD in the United States. However, the longer dialysis time and the lower blood flow rate are not likely to increase the rate of adverse events. Adverse events (including Serious Adverse Events) will be collected at each treatment whenever they occur and will be analyzed using descriptive statistics.
This is a prospective double-armed study of 2 years of Lixelle®-treatment. The study consists of the study arm of 2 years of Lixelle®-treatment in 30 DRA patients and the natural history arm of 2 years of conventional HD in 10 DRA patients as the descriptive reference.
The primary objective of this study is to assess the safety of Lixelle® in patients in the USA. The secondary objectives of this study are to assess the probable benefit of Lixelle® to increase the β2M reduction rate in a single dialysis session.
Exploratory endpoints are to assess:
- the changes of DRA symptoms and ADL of the patients treated with Lixelle® using DRAQ (Dialysis-Related Amyloidosis Questionnaire)
- the changes of QOL of the patients treated with Lixelle® using KDQOL-SF (Kidney Disease Quality of Life Short Form)
- the pre-treatment β2M levels at baseline, one and two years; and
- bone cysts at baseline and two years
- Conditions
- Dialysis Amyloidosis
- Being tested
- Lixelle® treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lixelle® treatmentDevice
The treatment will be performed with the Lixelle® column connected to upstream of the dialyzer in series on the routine HD circuit according to the description in the IFU. The dialyzer and the Kt/V urea in the conventional HD for each patient will be kept equal in Lixelle®-treatment. Since the maximum blood flow rate for Lixelle® is 250 ml/min, the dialysis time will be extended to achieve the target Kt/V urea. The study will not restrict the type of hemodialyzer and other conditions of HD as specified by the physician. However, any changes to the HD procedure should be recorded properly, and the Kt/V urea should be kept equal to that at the enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Lixelle® treatment | Experimental | 2 years of Lixelle® treatment in the patients with dialysis related amyloidosis (DRA) Receives: Device: Lixelle® treatment |
| natural history | No intervention | 2 years of natural history in the patients with dialysis related amyloidosis (DRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of SAE
comparison of incidence of SAE between between the Lixelle® treatment group and the natural history during treatment period (2 years)
Measured: through 2 years of Lixelle® treatment during the study period
Secondary outcomes (2)
β2M reduction rate in Lixelle® treatment (2 year)
to compare how much blood β2M level have decreased after after Lixelle® treatment against pre-treatment level.
Measured: comparison between baseline and 2 years (104 weeks) after Lixelle® treatment
comparison of β2M reduction rate between Lixelle® treatment and natural history
to compare β2M reduction rate (see Description in Outcome 2) between the Lixelle® treatment grroup and tne natural history group.
Measured: comparison between baseline and 2 years (104 weeks) after Lixelle® treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study start1 Oct 2015
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Why it stopped: Ongoing adjustments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Dialysis AmyloidosisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaneka Medical America LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Silberzweig, MD, Principal investigator, The Rogosin Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952144
- Sponsor's protocol ID
- KPA-Lixelle-001
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2016
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Argiles A, Mourad G, Kerr PG, Garcia M, Collins B, Demaille JG. Cells surrounding haemodialysis-associated amyloid deposits are mainly macrophages. Nephrol Dial Transplant. 1994;9(6):662-7. doi: 10.1093/ndt/9.6.662.
PubMed 7970093Inoue H, Saito I, Nakazawa R, Mukaida N, Matsushima K, Azuma N, Suzuki M, Miyasaka N. Expression of inflammatory cytokines and adhesion molecules in haemodialysis-associated amyloidosis. Nephrol Dial Transplant. 1995 Nov;10(11):2077-82.
PubMed 8643171Chertow GM, Trimbur T, Karlson EW, Lazarus JM, Kay J. Performance characteristics of a dialysis-related amyloidosis questionnaire. J Am Soc Nephrol. 1996 Aug;7(8):1235-40. doi: 10.1681/ASN.V781235.
PubMed 8866418Carmichael P, Popoola J, John I, Stevens PE, Carmichael AR. Assessment of quality of life in a single centre dialysis population using the KDQOL-SF questionnaire. Qual Life Res. 2000 Mar;9(2):195-205. doi: 10.1023/a:1008933621829.
PubMed 10983483Kutsuki H. beta(2)-Microglobulin-selective direct hemoperfusion column for the treatment of dialysis-related amyloidosis. Biochim Biophys Acta. 2005 Nov 10;1753(1):141-5. doi: 10.1016/j.bbapap.2005.08.007. Epub 2005 Sep 6.
PubMed 16168723Gejyo F, Yamada T, Odani S, Nakagawa Y, Arakawa M, Kunitomo T, Kataoka H, Suzuki M, Hirasawa Y, Shirahama T, et al. A new form of amyloid protein associated with chronic hemodialysis was identified as beta 2-microglobulin. Biochem Biophys Res Commun. 1985 Jun 28;129(3):701-6. doi: 10.1016/0006-291x(85)91948-5.
PubMed 3893430Gejyo F, Odani S, Yamada T, Honma N, Saito H, Suzuki Y, Nakagawa Y, Kobayashi H, Maruyama Y, Hirasawa Y, et al. Beta 2-microglobulin: a new form of amyloid protein associated with chronic hemodialysis. Kidney Int. 1986 Sep;30(3):385-90. doi: 10.1038/ki.1986.196.
PubMed 3537446Gejyo F, Homma N, Arakawa M. Carpal tunnel syndrome and beta 2-microglobulin-related amyloidosis in chronic hemodialysis patients. Blood Purif. 1988;6(2):125-31. doi: 10.1159/000169494. No abstract available.
PubMed 3293616Miyata T, Oda O, Inagi R, Iida Y, Araki N, Yamada N, Horiuchi S, Taniguchi N, Maeda K, Kinoshita T. beta 2-Microglobulin modified with advanced glycation end products is a major component of hemodialysis-associated amyloidosis. J Clin Invest. 1993 Sep;92(3):1243-52. doi: 10.1172/JCI116696.
PubMed 8376584Abe T, Uchita K, Orita H, Kamimura M, Oda M, Hasegawa H, Kobata H, Fukunishi M, Shimazaki M, Abe T, Akizawa T, Ahmad S. Effect of beta(2)-microglobulin adsorption column on dialysis-related amyloidosis. Kidney Int. 2003 Oct;64(4):1522-8. doi: 10.1046/j.1523-1755.2003.00235.x.
PubMed 12969174Gejyo F, Kawaguchi Y, Hara S, Nakazawa R, Azuma N, Ogawa H, Koda Y, Suzuki M, Kaneda H, Kishimoto H, Oda M, Ei K, Miyazaki R, Maruyama H, Arakawa M, Hara M. Arresting dialysis-related amyloidosis: a prospective multicenter controlled trial of direct hemoperfusion with a beta2-microglobulin adsorption column. Artif Organs. 2004 Apr;28(4):371-80. doi: 10.1111/j.1525-1594.2004.47260.x.
PubMed 15084199
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Dialysis-Related Amyloidosis Using Lixelle® β2-microglobulin Apheresis Column
- ClinicalTrials.gov ID
- NCT02952144
- Acronym / sponsor ID
- KPA-Lixelle-001
- Conditions
- Dialysis Amyloidosis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Ongoing adjustments
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaneka Medical America LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 2 Nov 2016 (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.
Dialysis-related amyloidosis (DRA) is a serious complication of long-term hemodialysis (HD). Its pathogenic mechanism involves accumulation of β2-microglobulin (β2M) in the blood. β2M is produced by most cells in the body and is metabolized in the kidney in healthy individuals. However, in HD patients with renal dysfunction, β2M which is not removed entirely by HD accumulates excessively in the blood. Then it forms amyloid fibrils that are deposited in bones, joints, and soft tissues. The fibrils are further modified by advanced glycation end products (AGE), inducing local macrophage infiltration and production of cytokines leading to chronic inflammation and activation of osteoclasts. Consequently, severe complications with various symptoms are developed, which are collectively referred to as DRA.
Lixelle® is a whole-blood β2M apheresis column developed to adsorb and eliminate β2M selectively from the blood of DRA patients. The treatment is performed with Lixelle® connected upstream of the dialyzer in series on a HD circuit in every session. The Lixelle® column contains porous cellulose beads with covalently linked hexadecyl alkyl chain ligands, which selectively adsorb β2M, via a molecular sieving effect because of its porous structure and hydrophobic interaction with ligands. Lixelle® has been used to relieve symptoms and prevent the progression of DRA in Japan since 1996, when health insurance coverage and reimbursement for the treatment were approved by Japanese Ministry of Health, Labor, and Welfare. Improvement of the activities of daily living (ADL) and remission of arthralgia by Lixelle® treatment has been shown in several clinical studies.
Detailed description
In a post-market study on Lixelle® conducted between 1994 and 1997 in Japan, all adverse events in 183 patients (13, 476 treatments) at 58 centers were collected. The most frequent adverse events were temporary hypotension and anemia, which are common in dialysis or any extracorporeal therapy. Since the maximum blood flow rate for Lixelle® is less than the average blood flow rate for the conventional HD in the USA, Lixelle®- treatment requires a longer treatment time to achieve the same Kt/V urea as the conventional HD in the United States. However, the longer dialysis time and the lower blood flow rate are not likely to increase the rate of adverse events. Adverse events (including Serious Adverse Events) will be collected at each treatment whenever they occur and will be analyzed using descriptive statistics.
This is a prospective double-armed study of 2 years of Lixelle®-treatment. The study consists of the study arm of 2 years of Lixelle®-treatment in 30 DRA patients and the natural history arm of 2 years of conventional HD in 10 DRA patients as the descriptive reference.
The primary objective of this study is to assess the safety of Lixelle® in patients in the USA. The secondary objectives of this study are to assess the probable benefit of Lixelle® to increase the β2M reduction rate in a single dialysis session.
Exploratory endpoints are to assess:
- the changes of DRA symptoms and ADL of the patients treated with Lixelle® using DRAQ (Dialysis-Related Amyloidosis Questionnaire)
- the changes of QOL of the patients treated with Lixelle® using KDQOL-SF (Kidney Disease Quality of Life Short Form)
- the pre-treatment β2M levels at baseline, one and two years; and
- bone cysts at baseline and two years
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lixelle® treatment | Experimental | Device: Lixelle® treatment2 years of Lixelle® treatment in the patients with dialysis related amyloidosis (DRA) |
| natural history | No intervention | –2 years of natural history in the patients with dialysis related amyloidosis (DRA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients receiving thrice-weekly HD and diagnosed as DRA by one or more of the following 1 to 4 will be included.
Key exclusion criteria (9 listed)
- Patient who meets any of the following 1 to 7 will be excluded from the study.
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 |
|---|---|---|
| Lixelle® treatmentThe treatment will be performed with the Lixelle® column connected to upstream of the dialyzer in series on the routine HD circuit according to the description in the IFU. The dialyzer and the Kt/V urea in the conventional HD for each patient will be kept equal in Lixelle®-treatment. Since the maximum blood flow rate for Lixelle® is 250 ml/min, the dialysis time will be extended to achieve the target Kt/V urea. The study will not restrict the type of hemodialyzer and other conditions of HD as specified by the physician. However, any changes to the HD procedure should be recorded properly, and the Kt/V urea should be kept equal to that at the enrollment. | Device | Lixelle® treatment |
Primary outcome
the rate of SAE
Time frame: through 2 years of Lixelle® treatment during the study period
comparison of incidence of SAE between between the Lixelle® treatment group and the natural history during treatment period (2 years)
2 secondary outcomes
β2M reduction rate in Lixelle® treatment (2 year)
Time frame: comparison between baseline and 2 years (104 weeks) after Lixelle® treatment
comparison of β2M reduction rate between Lixelle® treatment and natural history
Time frame: comparison between baseline and 2 years (104 weeks) after Lixelle® treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Background: PubMed 7970093Argiles A, Mourad G, Kerr PG, Garcia M, Collins B, Demaille JG. Cells surrounding haemodialysis-associated amyloid deposits are mainly macrophages. Nephrol Dial Transplant. 1994;9(6):662-7. doi: 10.1093/ndt/9.6.662.
- Background: PubMed 8643171Inoue H, Saito I, Nakazawa R, Mukaida N, Matsushima K, Azuma N, Suzuki M, Miyasaka N. Expression of inflammatory cytokines and adhesion molecules in haemodialysis-associated amyloidosis. Nephrol Dial Transplant. 1995 Nov;10(11):2077-82.
- Background: PubMed 8866418Chertow GM, Trimbur T, Karlson EW, Lazarus JM, Kay J. Performance characteristics of a dialysis-related amyloidosis questionnaire. J Am Soc Nephrol. 1996 Aug;7(8):1235-40. doi: 10.1681/ASN.V781235.
- Background: PubMed 10983483Carmichael P, Popoola J, John I, Stevens PE, Carmichael AR. Assessment of quality of life in a single centre dialysis population using the KDQOL-SF questionnaire. Qual Life Res. 2000 Mar;9(2):195-205. doi: 10.1023/a:1008933621829.
- Background: PubMed 16168723Kutsuki H. beta(2)-Microglobulin-selective direct hemoperfusion column for the treatment of dialysis-related amyloidosis. Biochim Biophys Acta. 2005 Nov 10;1753(1):141-5. doi: 10.1016/j.bbapap.2005.08.007. Epub 2005 Sep 6.
- Results publication: PubMed 3893430Gejyo F, Yamada T, Odani S, Nakagawa Y, Arakawa M, Kunitomo T, Kataoka H, Suzuki M, Hirasawa Y, Shirahama T, et al. A new form of amyloid protein associated with chronic hemodialysis was identified as beta 2-microglobulin. Biochem Biophys Res Commun. 1985 Jun 28;129(3):701-6. doi: 10.1016/0006-291x(85)91948-5.
- Results publication: PubMed 3537446Gejyo F, Odani S, Yamada T, Honma N, Saito H, Suzuki Y, Nakagawa Y, Kobayashi H, Maruyama Y, Hirasawa Y, et al. Beta 2-microglobulin: a new form of amyloid protein associated with chronic hemodialysis. Kidney Int. 1986 Sep;30(3):385-90. doi: 10.1038/ki.1986.196.
- Results publication: PubMed 3293616Gejyo F, Homma N, Arakawa M. Carpal tunnel syndrome and beta 2-microglobulin-related amyloidosis in chronic hemodialysis patients. Blood Purif. 1988;6(2):125-31. doi: 10.1159/000169494. No abstract available.
- Results publication: PubMed 8376584Miyata T, Oda O, Inagi R, Iida Y, Araki N, Yamada N, Horiuchi S, Taniguchi N, Maeda K, Kinoshita T. beta 2-Microglobulin modified with advanced glycation end products is a major component of hemodialysis-associated amyloidosis. J Clin Invest. 1993 Sep;92(3):1243-52. doi: 10.1172/JCI116696.
- Results publication: PubMed 12969174Abe T, Uchita K, Orita H, Kamimura M, Oda M, Hasegawa H, Kobata H, Fukunishi M, Shimazaki M, Abe T, Akizawa T, Ahmad S. Effect of beta(2)-microglobulin adsorption column on dialysis-related amyloidosis. Kidney Int. 2003 Oct;64(4):1522-8. doi: 10.1046/j.1523-1755.2003.00235.x.
- Results publication: PubMed 15084199Gejyo F, Kawaguchi Y, Hara S, Nakazawa R, Azuma N, Ogawa H, Koda Y, Suzuki M, Kaneda H, Kishimoto H, Oda M, Ei K, Miyazaki R, Maruyama H, Arakawa M, Hara M. Arresting dialysis-related amyloidosis: a prospective multicenter controlled trial of direct hemoperfusion with a beta2-microglobulin adsorption column. Artif Organs. 2004 Apr;28(4):371-80. doi: 10.1111/j.1525-1594.2004.47260.x.
- Individual participant dataSharing planned: No
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.
Jeffrey Silberzweig, MD principal investigator
The Rogosin Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lixelle® treatment in people with Dialysis Amyloidosis, run by Kaneka Medical America LLC 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 5 inclusion and 9 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: paused, as of the sponsor's last update on 31 Aug 2026. 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. 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?
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?
the rate of SAE (time frame: through 2 years of Lixelle® treatment during the study period). 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 NCT02952144, which also lists 11 linked publications.
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 31 Aug 2026.