← Back to Search

Unknown

Long-Term Safety of KT-301 for Chronic Kidney Disease

Phase 2 & 3

Recruiting

Research Sponsored by Kibow Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is to study the long-term safety and effectiveness of a drug in people with CKD who have already completed a study on the same drug.

Who is the study for?

This trial is for adults aged 18-80 with Chronic Kidney Disease (CKD) stage IV who finished the US-APR2020-01 study. It's not open to those who didn't participate or withdrew from that initial study, or can't commit to follow-up visits.Check my eligibility

What is being tested?

The trial is testing the long-term safety and effectiveness of a drug called KT-301 in patients with CKD IV. This extension follows an earlier phase where participants already received this treatment.See study design

What are the potential side effects?

Since this is an extension of a previous trial, side effects are likely similar to those observed before which may include issues related to kidney function, blood pressure changes, and potential impacts on other organ systems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the clinical efficacy of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV

Evaluate the long-term safety of KT-301 (formerly US-APR2020) in patients with Chronic Kidney Disease (CKD) Stage IV

Secondary outcome measures

Evaluate changes in basic blood uremic metabolic markers

Evaluate changes in complete blood count and hematology parameters

Percent change in rating scale (Modified SF36 QOL questionnaire) from roll-over transition until study competition (at 24-weeks)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: KT-301 (formerly US-APR2020)Experimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kibow PharmaLead Sponsor

5 Previous Clinical Trials

901 Total Patients Enrolled

Frequently Asked Questions

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

Does this research include seniors as participants?

"This study is only taking patients that are aged 18-80. There are other trials available for both younger and older patients."

Answered by AI

Are we presently enrolling participants for this research project?

"The trial is recruiting patients, as of 10/11/2022, and began recruiting on 4/21/2022 according to the listing on clinicaltrials.gov."

Answered by AI

How can I sign up for this opportunity to test a new medication?

"This study is looking for 600 individuals who have stage 4 chronic kidney disease and meet the following additional requirements: being 18-80 years old and having completed the US-APR2020-01 study."

Answered by AI

How many people are being recruited for this experiment?

"In order for this 600-person clinical study to be completed, patients that meet the given criteria must enroll. These individuals can visit one of the many participating locations, such as South carolina Clinical Research in Orangeburg, South Carolina and Mendez Center for Clinical Research in Woodbridge, Virginia."

Answered by AI

At how many locations is this trial currently taking place?

"This trial is recruiting at several locations, which include South carolina Clinical Research in Orangeburg, South Carolina, Mendez Center for Clinical Research in Woodbridge, Virginia, Kidney Michigan in Saginaw, Michigan, and 5 other sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study

2022. "Rollover Extension Clinical Trial To Evaluate The Long-Term Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With CKD IV Completing The US-APR2020-01 Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05407389.