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Phosphate Binder

ILY101 for Hyperphosphatemia in Kidney Disease

Phase 2
Waitlist Available
Research Sponsored by Ilypsa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CKD patients on dialysis
Prior successful use of phosphate binder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new treatment for kidney disease patients with high levels of phosphate in their blood. It will last about 10 weeks, and researchers want to see if it is safe and effective.

Who is the study for?
This trial is for chronic kidney disease patients who are on dialysis and have high phosphate levels. They should have previously used phosphate binders successfully. It's not for those with a history of intolerance to similar treatments, significant liver issues, upcoming kidney transplants, major gut problems, or pregnant/breastfeeding women not using birth control.Check my eligibility
What is being tested?
The study tests the effectiveness and tolerability of a drug called ILY101 in managing high phosphate levels in dialysis patients. Participants will be randomly assigned different doses of ILY101 over approximately 10 weeks to determine the best balance between benefits and side effects.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical concerns may include digestive issues due to the nature of phosphate binders, potential allergic reactions, or complications related to existing conditions like liver disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a patient with chronic kidney disease on dialysis.
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I have used phosphate binders successfully before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Find a Location

Who is running the clinical trial?

IlypsaLead Sponsor
Guido Smeets, MDStudy DirectorIlypsa

Media Library

ILY101 (Phosphate Binder) Clinical Trial Eligibility Overview. Trial Name: NCT00358046 — Phase 2
Kidney Failure Research Study Groups:
Kidney Failure Clinical Trial 2023: ILY101 Highlights & Side Effects. Trial Name: NCT00358046 — Phase 2
ILY101 (Phosphate Binder) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00358046 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to enroll in this experiment?

"This medical trial is seeking 120 individuals, aged 18 to 80, currently diagnosed with kidney diseases. Essential inclusion criteria for possible participants include: CKD patients on dialysis treatment, a history of using phosphate binder successfully and a signed consent form confirming understanding of the study details."

Answered by AI

Has this treatment been greenlit by the FDA?

"Although there is a certain level of safety data available, efficacy has yet to be confirmed. Therefore it was given an overall rating of 2 on our risk assessment scale."

Answered by AI

How many healthcare facilities are presently carrying out this investigation?

"18 medical centres are currently accepting applications for this trial, including those located in Baton Rouge, Salt Lake City and Norfolk. Prospective participants should look to choose the facility that is closest to them in order to limit travelling demands."

Answered by AI

Does the experimental protocol involve participants older than 30?

"To be eligible for this medical trial, patients must fall within the 18 to 80 age bracket. For those younger than 18 and older than 65, there are 46 and 562 studies respectively."

Answered by AI

Is this project still recruiting participants?

"The clinicaltrials.gov portal has not been updated with regards to this medical trial since February 5th 2007, implying it is no longer looking for applicants. Although the study is inactive, there are 604 other trials actively recruiting patients at present."

Answered by AI
~6 spots leftby Apr 2025