Patients will receive standard of care behavior and nutritional interventions. They will not receive cyproheptadine.

Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used.

Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for two weeks cycled with no cyproheptadine given for two weeks for a total of two months. Patients on cycled dosing will be given cyproheptadine for two weeks, then no medication for two weeks; repeating this cycle for the two month duration of study

No Cyproheptadine Treatment

Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for a total of two months. Standard dose of 0.25 mg/kg divided BID will be used.
Cyproheptadine

Continuous Cyproheptadine

Patients will receive standard of care behavior and nutritional interventions. They will receive cyproheptadine every day for two weeks cycled with no cyproheptadine given for two weeks for a total of two months. Patients on cycled dosing will be given cyproheptadine for two weeks, then no medication for two weeks; repeating this cycle for the two month duration of study
Cyproheptadine

Cycled Cyproheptadine

Total

Sex: Female, Male

Region of Enrollment

Participants' guardians will complete the Mealtime Behavior Questionnaire (MBQ). This is a validated, 31-item, parent-report questionnaire assessing the mealtime behavior structure in young children above 2 years. The questionnaire measures variables including: 1) food refusals/avoidance; 2) food manipulation; 3) mealtime aggression and 4) choking/gagging/vomiting related to meals. Each behavior is assigned a frequency scale with 1 corresponding to "never" and 5 corresponding to "always." The MBQ then consist of a total score and four subcategory scores (listed above).

Feeding Behavior Questionnaire

Change in skin fold thickness as measured by centimeters and z-score percentiles

Anthropometrics: Skin Fold Thickness

Change in mid-arm circumference as measure by centimeters and z-score percentiles

Anthropometrics: Mid-arm Circumference

Change in BMI as measured by kilograms divided by meters squared and z-score percentiles

Anthropometrics: BMI

Change in height as measured in centimeters and z-score percentiles

Anthropometrics: Height

Change in weight as measured in kilograms and z-score percentiles

Anthropometrics: Weight

Patients will answer affirmative or negative to a descriptive list of side effects commonly experienced when taking cyproheptadine. Examples of these descriptive variables include nausea, emesis, etc. Percentage of patients experiencing each side effect will be calculated and compared across the course of study.

Percentage of Participants Experiencing Side Effects From Cyproheptadine

Change in calorie intake will be recorded

24 Hour Diet Recall

Overall Study

Praveen Goday

Feeding Behaviors

Cyproheptadine

Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders

Professor of Pediatric Gastroenterology

Medical College of Wisconsin

Patients will receive two cycles of Placebo (NaCl solution) at an interval of three months.
Each cycle will consist of intravenously administered (within 3-5 seconds) Placebo twice weekly on days 1, 4, 8 and 11.

Patients will receive two cycles of Bortezomib (Velcade®) at an interval of three months.
Each cycle will consist of intravenously administered (within 3-5 seconds) Bortezomib 1.3 mg/m2 twice weekly on days 1, 4, 8 and 11.

Late Rejection of Renal Transplant

Antibody-mediated Rejection

Bortezomib

Placebo

Medical University of Vienna, Department of Nephrology and Dialysis

Bortezomib in Late Antibody-mediated Kidney Transplant Rejection

Bortezomib in Late Antibody-mediated Kidney Transplant Rejection (BORTEJECT Study)

Peripheric venous blood samples (4ml) will be obtained after 0, 6, 12, 18 an 24 months to assess the change of eGFR slopes over time.
In case of loss of follow-up the GFR is assumed to be 0ml/min.

Peripheric venous blood samples (10mL) will be obtained after 0, 6, 12, 18 and 24 months to assess DSA levels by Luminex® technology.
Maximum and sum of MFI of DSA
Number of DSA
Broadness of sensitization (virtual PRA)

Survival will be assessed after 12 and 24 months after randomization

Graft loss will be assessed after 12 and 24 months after randomization with or without re-transplantation

Cr-EDTA GFR will be assessed by measuring the clearance of a defined peripheric administered dose of Chromium-51 EDTA according to a standard protocol.

Protein excretion (protein/creatinine ratio) will be measured in 24h urine at 0, 6, 12, 18 and 24 months after randomization.

Diagnosed at protocol biopsy after month 24 after randomization or whenever clinically indicated

Acute AMR score (0-9)
Sum of:
Glomerulitis 0, 1, 2, 3
Peritubular capillaritis 0, 1, 2, 3
C4d in peritubular capillaries 0, 1, 2, 3

Chronic AMR score (0-9)
Sum of:
Transplant glomerulopathy 0, 1, 2, 3
Peritubular capillary basement membrane lamellation 0, 1, 2, 3
Chronic vasculopathy 0, 1, 2, 3

hallucinations/diarrhea

Effects of Cyproheptadine on Growth and Behavior in Pediatric Feeding Disorders

Bortezomib in Late Antibody-mediated Kidney Transplant Rejection

Plasma and Abscess Fluid Pharmacokinetics of Cefpirome and Moxifloxacin After Single and Multiple Dose Administration

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