On-going Trials at Tulane

Cytochroma Vitamin D Study

Contact Annie Stell 988-6834 or cstell@tulane.edu.

Inclusion Criteria

Each subject must meet the following criteria to be enrolled in this study:

  1. Between 18 and 85 years of age, inclusive
  2. Stage 3 or 4 CKD, as confirmed by medical history and eGFR (15 and <60 mL/min/1.73m2), good general health and absence of any disease state or physical condition that might impair evaluation of safety or which, in the investigator’s opinion, would interfere with study participation
  3. Urinary albumin (Alb) excretion 3000 μg/mg (3 mg/mg) creatinine (Cr)
  4. From both visit 1 (or visit 2 for subjects requiring washout) and visit 3:
    • a. Plasma iPTH 85 pg/mL and <500 pg/mL
    • b. Serum Ca 8.4 mg/dL and <9.8 mg/dL
    • c. Serum P 2.0 mg/dL and <5.0 mg/dL
    • d. Serum total 25D 10 ng/mL and <30 ng/mL
  5. If taking more than 1000 mg/day of elemental Ca, willing and able to discontinue or reduce Ca use and/or use non-Ca based therapies for the duration of the study and undergo at least a 14-day washout prior to visit 2
  6. If taking more than 1600 IU of vitamin D (ergocalciferol or cholecalciferol), willing and able to discontinue or reduce vitamin D therapy for at least 2 months prior to and randomization, agree to remain on that dose during the study and undergo at least a 28- day washout prior to visit 2
  7. Subjects taking other bone metabolism therapy (with the exception of bisphosphonates) that may interfere with study endpoints must be willing and able to discontinue use of these agents for the duration of the study and allow for at least a 28-day washout prior to visit 2
  8. Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
  9. Has stable kidney function in the medical judgment of the investigator and is not expected to require dialysis or kidney transplant within 6 months of screening
  10. Female subject of childbearing potential is neither pregnant nor lactating and must have a negative urine pregnancy test at visit 1
  11. All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study
  12. Has the ability to read and understand subject Informed Consent Form (ICF). Subject or their legal representative must sign the ICF

 Exclusion Criteria

 Subjects who meet any of the following criteria will be excluded from the study:

  1. History of kidney transplant or parathyroidectomy
  2. Use of pharmacological dose of ergocalciferol or cholecalciferol (50,000 IU/1250 μg per month) within 2 months prior to randomization and during the study
  3. Spot urine Ca:Cr ratio >0.2 (>200 mg/g Cr)
  4. Bisphosphonate therapy within 6 months prior to enrollment and during the study
  5. Known previous or concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis that in the opinion of the investigator may worsen and/or interfere with participation in the study
  6. History of neurological/psychiatric disorder, including psychotic disorder or dementia, or any reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely
  7. Known or suspected hypersensitivity to any of the constituents of either investigational product
  8. Currently participating in, or has participated in, an interventional/investigation

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