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Clinical Trial in Healthy Volunteers and Subjects With CDK

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ClinicalTrials.gov Identifier: NCT03893799
Recruitment Status : Not yet recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Renibus Therapuetics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: Iron sucrose (FeS) and Tin Protoporphyrin (SnPP) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 1b Dose-escalating Study With RBT-1, in Healthy Volunteers and Subjects With Chronic Kidney Disease Stage 3b-4
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Administer a dose 12mgFeS/9mg SnPP
12 healthy volunteers will be administered a single dose of 12 mg Iron Sucrose and 9 mg of Tin Protoporphyrin and followed for seven days.
Drug: Iron sucrose (FeS) and Tin Protoporphyrin (SnPP)
Escalating doses of iron sucrose and tin protoporphyrin

Administer a dose 60mgFeS/45 mg SnPP
12 healthy volunteers will be administered a single dose of 60 mg of Iron Sucrose and 45 mg of Tin Protoporphyrin and followed for seven days.
Drug: Iron sucrose (FeS) and Tin Protoporphyrin (SnPP)
Escalating doses of iron sucrose and tin protoporphyrin

Administer a dose 120mgFeS/90mg SnPP
12 healthy volunteers will be administered a single dose of 120 mg of Iron Sucrose and 90 mg of Tin Protoporphyrin and followed for seven days.
Drug: Iron sucrose (FeS) and Tin Protoporphyrin (SnPP)
Escalating doses of iron sucrose and tin protoporphyrin

Administer a dose 180mgFeS/135mg SnPP
12 healthy volunteers will be administered a single dose of 180 mg and 135 mg of Tin Protoporphyrin and followed for seven days.
Drug: Iron sucrose (FeS) and Tin Protoporphyrin (SnPP)
Escalating doses of iron sucrose and tin protoporphyrin

Administer a dose of FeS/SnPP CKD Arm
12 subjects with stage 3 or 4 CKD will be administered a single dose of Iron Sucrose and Tin Protoporphyrin selected from the highest dose from the prior arm that evidences the best safety profile. The subjects will be followed for seven days.
Drug: Iron sucrose (FeS) and Tin Protoporphyrin (SnPP)
Escalating doses of iron sucrose and tin protoporphyrin




Primary Outcome Measures :
  1. Effect of RBT-1 on biomarkers of cytoprotective activity [ Time Frame: 7 days ]
    Measuring Haptoglobin, Ferritin, Bilirubin, Hemopexin, IL-10, and Heme Oxygenase-1, the P21 biomarker systemic levels


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 7 days ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Establish the optimal dose for future development [ Time Frame: 60 days ]
    The highest dose of RBT-1 with the best safety and tolerability will be determined



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects age 18 to 80 years (inclusive, at time of ICF).
  2. Body weight <125 kg.
  3. Able and willing to comply with all study procedures.
  4. 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.

  5. 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:

  1. History of malignancy except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers.
  2. Use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever is longer.
  3. Serum ferritin > 500 ng/ml or who have received IV iron within 28 days of screening, or currently being treated with oral iron.
  4. Women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study.
  5. Regular use of drugs of abuse and/or positive findings on urinary drug screening.
  6. Current tobacco use and/or positive findings on urinary cotinine screening.
  7. 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.
  8. 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.
  9. Known hypersensitivity or previous anaphylaxis to RBT-1 or to components thereof. -

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Responsible Party: Renibus Therapuetics, Inc.
ClinicalTrials.gov Identifier: NCT03893799     History of Changes
Other Study ID Numbers: REMN-001
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Iron
Ferric Oxide, Saccharated
Protoporphyrin IX
Tin protoporphyrin IX
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Photosensitizing Agents
Dermatologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action