Kidney DiseasesPhase 2NCT00358046
Efficacy and Tolerability of ILY101 in Dialysis Patients With Hyperphosphatemia
A Phase 2 study testing ILY101 in people with Kidney Diseases and Renal Insufficiency, run by Ilypsa at 18 sites in United States.
Trial summary
This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Diseases, Renal Insufficiency
- What is being tested?
- ILY101
- How many people
- 120 participants
- Where
- 18 sitesUnited States
- Study dates
- Jun 2006to 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD patients on dialysis
- Prior successful use of phosphate binder
- Signed informed consent
Who cannot join
- Previous intolerance to polymer-based phosphate binders
- Kidney transplant planned within 3 months
- Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control
- Clinically significant liver disease
- History of bowel obstruction or other significant gastrointestinal disorder
- Additional study entry criteria will be evaluated during initial screening.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Clinical Study Site
Allentown, Pennsylvania
Clinical Study Site
Appleton, Wisconsin, 54911
Clinical Study Site
Baton Rouge, Louisiana
Clinical Study Site
Des Moines, Iowa
Clinical Study Site
Houston, Texas
Clinical Study Site
Mobile, Alabama
Clinical Study Site
Mountain View, California
Clinical Study Site
Norfolk, Virginia
Clinical Study Site
Ocala, Florida
Clinical Study Site
Palm Beach Gardens, Florida
Clinical Study Site
Pembroke Pines, Florida
Clinical Study Site
Provo, Utah
Clinical Study Site
Riverside, California
Clinical Study Site
Rochester, New York
Clinical Study Site
Salt Lake City, Utah
Clinical Study Site
San Antonio, Texas
Clinical Study Site
San Diego, California
Clinical Study Site
Thornton, Colorado
About this study
Official title: A Phase 2, Randomized, Dose-Ranging, Single-Blind, Efficacy and Tolerability Study of ILY101 in Patients With Chronic Kidney Disease With Hyperphosphatemia on Hemodialysis
This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration.
Read the detailed description
Hyperphosphatemia is associated with abnormally high blood concentrations of phosphorus. Normally, phosphorus in the body is excreted into urine via the kidneys, but this process is impaired when renal function is reduced. Hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. High blood phosphorus concentrations trigger various complications caused by phosphorous interaction with blood calcium or parathyroid hormones, and makes patients more prone to calcium deposition in soft tissues such as the coronary arteries, increasing the risk of ischemic heart disease. ILY101 is a non-absorbed, metal-free polymer that binds phosphorus in the gastrointestinal tract, allowing for excretion of phosphorus. It is therefore anticipated to ameliorate hyperphosphatemia by reducing the absorption of phosphorus from the gastrointestinal tract.
- Conditions
- Kidney Diseases, Renal Insufficiency
- Being tested
- ILY101
- Keywords
- Hyperphosphatemia, Chronic kidney disease, Dialysis, Hyperphosphatemia in CKD patients on dialysis
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Hyperphosphatemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILY101Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Ilypsa
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Guido Smeets, MD, Study director, Ilypsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358046
- Sponsor's protocol ID
- ILY-1201
- Status last verified
- Feb 2007
- First submitted
- 26 Jul 2006
- Last updated
- 7 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Dose-Ranging, Single-Blind, Efficacy and Tolerability Study of ILY101 in Patients With Chronic Kidney Disease With Hyperphosphatemia on Hemodialysis
- ClinicalTrials.gov ID
- NCT00358046
- Acronym / sponsor ID
- ILY-1201
- Conditions
- Kidney Diseases, Renal Insufficiency
- Keywords
- Hyperphosphatemia, Chronic kidney disease, Dialysis, Hyperphosphatemia in CKD patients on dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- IlypsaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- First posted
- 28 Jul 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.
This is a randomized, dose-ranging, efficacy and tolerability study in chronic kidney disease patients with hyperphosphatemia on hemodialysis. Patient participation in the study is approximately 10 weeks in duration.
Detailed description
Hyperphosphatemia is associated with abnormally high blood concentrations of phosphorus. Normally, phosphorus in the body is excreted into urine via the kidneys, but this process is impaired when renal function is reduced. Hyperphosphatemia occurs in many patients with renal insufficiency, especially those on dialysis. High blood phosphorus concentrations trigger various complications caused by phosphorous interaction with blood calcium or parathyroid hormones, and makes patients more prone to calcium deposition in soft tissues such as the coronary arteries, increasing the risk of ischemic heart disease. ILY101 is a non-absorbed, metal-free polymer that binds phosphorus in the gastrointestinal tract, allowing for excretion of phosphorus. It is therefore anticipated to ameliorate hyperphosphatemia by reducing the absorption of phosphorus from the gastrointestinal tract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CKD patients on dialysis
- Prior successful use of phosphate binder
- Signed informed consent
Key exclusion criteria (6 listed)
- Previous intolerance to polymer-based phosphate binders
- Kidney transplant planned within 3 months
- Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control
- Clinically significant liver disease
- History of bowel obstruction or other significant gastrointestinal disorder
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 |
|---|---|---|
| ILY101 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2007.
- Related InfoLink provided by the sponsor.
Related trials for Kidney Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
Guido Smeets, MD study director
Ilypsa
18 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 ILY101 in people with Kidney Diseases and Renal Insufficiency, run by Ilypsa at 18 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 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 18 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. 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?
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.
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 7 Feb 2007.