Back to resultsRBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD
Primary Purpose
Acute Kidney Injury
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FeS and SnPP
Sponsored by
About this trial
This is an interventional prevention trial for Acute Kidney Injury
Eligibility Criteria
Inclusion Criteria:
- Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
- Body weight <125 kg.
- Able and willing to comply with all study procedures.
Female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until 28 days after study drug administration.
Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 28 days after study drug administration. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
- CKD as determined by estimated glomerular filtration rate (GFR) between 15-45 ml/min as estimated using the CKD-EPI equation (CKD class 3b-4). -
Exclusion Criteria:
- History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.
- Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.
- Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening, or currently being treated with oral iron.
- Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
- Regular use of drugs of abuse and/or positive findings on urinary drug screening.
- Current tobacco use and/or positive findings on urinary cotinine screening.
- Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol.
- Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
- Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof. -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
Administer a dose 12mgFeS/9mg SnPP
Administer a dose 60mgFeS/45 mg SnPP
Administer a dose 120mgFeS/90mg SnPP
Administer a dose 180mgFeS/135mg SnPP
Administer a dose of FeS/SnPP CKD Arm
Arm Description
12 healthy volunteers will be administered a single dose of 12 mg Iron Sucrose and 9 mg of Stannous Protoporphyrin and followed for seven days.
12 healthy volunteers will be administered a single dose of 60 mg of Iron Sucrose and 45 mg of Stannous Protoporphyrin and followed for seven days.
12 healthy volunteers will be administered a single dose of 120 mg of Iron Sucrose and 90 mg of Stannous Protoporphyrin and followed for seven days.
12 healthy volunteers will be administered a single dose of 180 mg and 135 mg of Stannous Protoporphyrin and followed for seven days.
12 subjects with stage 3 or 4 CKD will be administered a single dose of Iron Sucrose and Stannous Protoporphyrin selected from the highest dose from the prior arm that evidences the best safety profile. The subjects will be followed for seven days.
Outcomes
Primary Outcome Measures
Effect of RBT-1 on biomarkers of cytoprotective activity
Measuring Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1, the P21 biomarker systemic levels
Secondary Outcome Measures
Adverse events
Safety and tolerability of RBT-1 in Healthy Volunteers and subjects with CKD
Establish the optimal dose for future development
The highest dose of RBT-1 with the best safety and tolerability will be determined
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03630029
Brief Title
RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD
Official Title
A Phase 1b Dose-escalating Study With RBT-1, in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3b-4
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The trial has been enhanced, a new NCT(NCT03893799) listing was created.
Study Start Date
September 15, 2018 (Anticipated)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
March 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renibus Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A Phase 1b study to evaluate the safety, tolerability and pharmacodynamic effect of RBT-1 in healthy volunteers and subjects with stage 3b-4 CKD.
Detailed Description
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, and pharmacodynamic effect of RBT-1 in healthy volunteers and in subjects with stage 3b-4 CKD. The following biomarkers will be used as surrogate measures of protective activity: Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1. Additionally, the P21 biomarker will be monitored at various points of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Administer a dose 12mgFeS/9mg SnPP
Arm Type
Other
Arm Description
12 healthy volunteers will be administered a single dose of 12 mg Iron Sucrose and 9 mg of Stannous Protoporphyrin and followed for seven days.
Arm Title
Administer a dose 60mgFeS/45 mg SnPP
Arm Type
Other
Arm Description
12 healthy volunteers will be administered a single dose of 60 mg of Iron Sucrose and 45 mg of Stannous Protoporphyrin and followed for seven days.
Arm Title
Administer a dose 120mgFeS/90mg SnPP
Arm Type
Other
Arm Description
12 healthy volunteers will be administered a single dose of 120 mg of Iron Sucrose and 90 mg of Stannous Protoporphyrin and followed for seven days.
Arm Title
Administer a dose 180mgFeS/135mg SnPP
Arm Type
Other
Arm Description
12 healthy volunteers will be administered a single dose of 180 mg and 135 mg of Stannous Protoporphyrin and followed for seven days.
Arm Title
Administer a dose of FeS/SnPP CKD Arm
Arm Type
Other
Arm Description
12 subjects with stage 3 or 4 CKD will be administered a single dose of Iron Sucrose and Stannous Protoporphyrin selected from the highest dose from the prior arm that evidences the best safety profile. The subjects will be followed for seven days.
Intervention Type
Drug
Intervention Name(s)
FeS and SnPP
Other Intervention Name(s)
FeS (Iron Sucrose) SnPP (Stannous Protoporpyhrin
Intervention Description
Escalating doses of drug will be compared for biomarker changes
Primary Outcome Measure Information:
Title
Effect of RBT-1 on biomarkers of cytoprotective activity
Description
Measuring Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1, the P21 biomarker systemic levels
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Adverse events
Description
Safety and tolerability of RBT-1 in Healthy Volunteers and subjects with CKD
Time Frame
7 days
Title
Establish the optimal dose for future development
Description
The highest dose of RBT-1 with the best safety and tolerability will be determined
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
Body weight <125 kg.
Able and willing to comply with all study procedures.
Female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from Screening until 28 days after study drug administration.
Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 28 days after study drug administration. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation.
CKD as determined by estimated glomerular filtration rate (GFR) between 15-45 ml/min as estimated using the CKD-EPI equation (CKD class 3b-4). -
Exclusion Criteria:
History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.
Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.
Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening, or currently being treated with oral iron.
Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
Regular use of drugs of abuse and/or positive findings on urinary drug screening.
Current tobacco use and/or positive findings on urinary cotinine screening.
Subjects who are severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol.
Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.
Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof. -
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RBT-1 Phase 1b Clinical Trial in Healthy Volunteers and Subjects With CKD
We'll reach out to this number within 24 hrs