AND017 for Kidney Anemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Kidney AnemiaAND017 - Drug
Eligibility
20 - 74
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a drug to see if it is safe and effective for patients with non-dialysis chronic kidney disease.

Eligible Conditions
  • Kidney Anemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: Baseline and at Week 3, 6, 9, 12, 14, and 28 days after the last dose

Week 10
Change in hemoglobin levels from baseline to the mean of weeks 10-13
Week 2
To assess changes in the levels of PD indicator - EPO
To assess changes in the levels of PD indicator - hepcidin
Week 3
Therapeutic procedure
To assess iron utilization parameter during treatment - transferrin level
To assess iron utilization parameter during treatment - transferrin saturation (TSAT)
To assess iron utilization parameters during treatment - ferritin
To assess iron utilization parameters during treatment - serum iron
Week 13
Change from baseline in Hb
Hemoglobin, Sickle
Percentage of patients who maintain hemoglobin between 10.0-11.0g/dL at each visit
Percentage of responder patients
Percentage of visits at which patients maintain hemoglobin between 10.0-11.0 g/dL after achieving hemoglobin ≥10.0 g/dL
Up to 17 weeks
Safety Evaluations
Week 5
Hb response to treatment during Period 1
Rate of rise in hemoglobin for each of 3 dose levels as compared with placebo from baseline to 5 weeks after TIW oral dosing
Week 13
Cumulative incidence of lack of response over the entire treatment period

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

AND017 Dose A
1 of 4
AND017 Dose B
1 of 4
AND017 Dose C
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

88 Total Participants · 4 Treatment Groups

Primary Treatment: AND017 · Has Placebo Group · Phase 2

AND017 Dose A
Drug
Experimental Group · 1 Intervention: AND017 · Intervention Types: Drug
AND017 Dose B
Drug
Experimental Group · 1 Intervention: AND017 · Intervention Types: Drug
AND017 Dose C
Drug
Experimental Group · 1 Intervention: AND017 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AND017
2020
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and at week 3, 6, 9, 12, 14, and 28 days after the last dose

Who is running the clinical trial?

Kind Pharmaceuticals LLCLead Sponsor
4 Previous Clinical Trials
273 Total Patients Enrolled
Yusha Zhu, MD PhDStudy DirectorKind Pharmaceuticals LLC
3 Previous Clinical Trials
153 Total Patients Enrolled

Eligibility Criteria

Age 20 - 74 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have chronic kidney disease, not receiving dialysis, with an eGFR <60 mL/min/1.
You have an abnormal result for the screening test.
You have serum folate and vitamin B12 levels that are normal at screening test.
If your total bilirubin is >1.

Who else is applying?

What state do they live in?
North Carolina100.0%
How old are they?
65+100.0%
What site did they apply to?
Metrolina Nephrology Associates100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%