Chronic Kidney Disease stage4 Clinical Trial
— CKDOfficial title:
A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial To Evaluate Safety And Efficacy Of KT-301 (Formerly US-APR2020) In Subjects With Chronic Kidney Disease Stage IV
Verified date | October 2022 |
Source | Kibow Pharma |
Contact | Mukesh Kumar, PhD |
Phone | 2407504893 |
mkumar[@]fdamap.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this Phase 2 study is to evaluate the safety and efficacy of the live biotherapeutic product, KT-301 (formerly US-APR2020), in the management of patients with CKD Stage IV.
Status | Recruiting |
Enrollment | 630 |
Est. completion date | December 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Adults between the ages of 18-80 years - CKD Stage IV (eGFR = 15-29 mL/min) with declining kidney function for a period > 6 months - Serum Creatinine > 2.0 mg/dL - Adherence to low protein diet (LPD) of 0.6-0.8 g/kg/day based on subject response and on advisory Exclusion Criteria: - Those on probiotic supplements in the past 3 months - Pregnancy, breast feeding or females of child-bearing potential who are unwilling to use a reliable form of contraception. - Immunosuppressant medications therapy specific to immune mediated renal diseases - HIV/AIDs - Underweight (BMI = 18.5) - Subject with an infection that requires oral antibiotic administration at the time of randomization or close to that visit. - Those with gastrointestinal disease (irritable bowel syndrome or anal fissures or anal fistulas or perianal abscesses or perianal infections or diverticular diseases or colitis or colon polyps) at the time of screening and randomization, or within 6 months prior to the randomization visit (Visit 2) - Those with internal prosthesis including orthopedics, neurosurgery, heart valves, vascular stents ? 2 years post -surgery procedure. Those with Prosthesis > 2 years should not be excluded. - Those with biological/tissue grafts or prosthesis or implant - Those on anticoagulant medicines, including Vit K antagonists (e.g., warfarin, coumadin) or the new class of oral anti-coagulants approved by FDA in the last 10 years - Those on peritoneal dialysis - Those with acute kidney injury - Those with mental conditions or medically debilitating disease/disorder other than CKD, which, in the judgment of the investigator, would interfere with or serve as a contraindication to adherence to the study protocol or affect the ability to give informed consent or affect overall prognosis of the patient. |
Country | Name | City | State |
---|---|---|---|
United States | Almeda Medical Clinic | Houston | Texas |
United States | South Carolina Clinical Research | Orangeburg | South Carolina |
United States | Kidney Michigan | Saginaw | Michigan |
United States | Jadedstone Clinical Research | Silver Spring | Maryland |
United States | Mendez Center for Clinical Research | Woodbridge | Virginia |
Lead Sponsor | Collaborator |
---|---|
Kibow Pharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate incidences of Treatment-Emergent Adverse Events following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of safety. | Presence of adverse events in less than 10% of the study population, as a measure of safety | six months | |
Primary | Evaluate the change of eGFR as per NKF-USFDA guidelines following KT-301 (formerly US-APR2020) administration in patients with Chronic Kidney disease (CKD) Stage IV as a measure of clinical efficacy. | Arresting the change of Estimated glomerular filtration rate (eGFR) as per National Kidney Foundation- US Food and Drug Administration (NKF-USFDA )guidelines in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo, as a measure of efficacy. | six months | |
Secondary | Evaluate changes in basic blood uremic metabolic markers | Change in any of the basic blood uremic metabolic markers in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo:
Blood Urea Nitrogen (BUN) Uric acid Serum creatinine Urea/creatinine ratio Micro albumin urea |
six months | |
Secondary | Evaluate changes in complete blood count and hematology parameters | Change in any of the complete blood count (CBC) and hematology parameters in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo:
Red blood cells White blood cells Platelets Hemoglobin (Hgb) Hematocrit (Hct) Ferritin |
six months | |
Secondary | Evaluate changes in C-Reactive Protein (CRP) levels | Change in C-Reactive Protein (CRP) levels in the group treated with KT-301 (formerly US-APR2020) as compared to the placebo | six months | |
Secondary | Evaluate change in quality of life (QOL)- SF36 QOL questionnaire | six months |
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