Please select the eligibility criteria that correspond to the clinical trial below.
Title: VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome
Brief Summary: The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.


Options:
A: Inclusion Criteria:

* Patients with a renal graft having been transplanted within the previous 8 years and being at least 3 months post transplantation, or, patients scheduled to undergo transplantation from a living organ donor within the upcoming 3 months
* Venous serum bicarbonate concentration \< 24 mmol/L at time of baseline determination
* Renal transplant function with a calculated glomerular filtration rate (GFR) greater or equal 30 ml/min according to the Cockcroft-Gault formula
* Immunosuppressive therapy including a calcineurin inhibitor (cyclosporine A or tacrolimus)
* Age 20 through 65 years of either sex
* Written informed consent for study participation

Exclusion Criteria:

* Acute rejection episode requiring specific therapy within 4 weeks before study inclusion
* Severe impairment in general health and/or physical handicaps (malignant neoplasia, catabolic state, acute systemic infection requiring therapy)
* Mental illness, psychiatric disorder
* Tetracycline intolerance
* Planned or "overt" pregnancy
B: Inclusion Criteria:

1. First or second kidney transplant recipients, aged 18-75 years, PTH \> 150 pg/ml
2. De novo patients scheduled to receive ciclosporin A and prednisolone based immunosuppression.

Exclusion Criteria:

1. Previous or current bone disease unrelated to end stage renal failure.
2. Patients with PTH \< 150pg/ml who may be at risk of adynamic bone disease.
3. Treatment at any time with a bisphosphonate.
4. d. Calcitonin treatment during the previous month.
5. Malignancy (current or history within last 5 years)
6. Pregnancy or lactation, or women of childbearing potential unwilling to use an effective form of contraception for the 12 month duration of the study.

Protocol-defined inclusion/exclusion criteria may apply.
C: Inclusion Criteria: Chronic Kidney Disease patients not receiving dialysis with: - An iPTH greater than 100 pg/mL \[10.6 pmol/L\] for subjects with stage 3 CKD or greater than or equal to 160 pg/mL \[17.0 pmol/L\] for subjects with stage 4 CKD; - A serum calcium greater than 9.0 mg/dL \[2.25 mmol/L\]; - An estimated GFR less than or equal to 59 mL/min and greater than or equal to 15 mL/min. Exclusion Criteria: - Have an unstable medical condition, defined as having been hospitalized within 30 days before day 1, or otherwise unstable in the judgment of the investigator. - Experienced a myocardial infarction (MI) within 3 months before day 1. - Likely to initiate dialysis (in the opinion of the investigator) or are scheduled to undergo renal transplantation within 28 weeks after day 1. - Received active vitamin D therapy (i.e., 1-hydroxylated metabolites of vitamin D) for less than 30 days before day 1 or required a change in active vitamin D brand or dose level within 30 days before day 1 (for patients prescribed active vitamin D).
D: Inclusion Criteria:

* age \> 18
* deceased donor kidney transplant recipients
* only kidney transplant recipients
* vitamin D deficiency defined as 25 (OH)D \< 50nmol/l

Exclusion Criteria:

* re-transplantation for the second time if the patient is highly immunized and therefore included in the aphaeresis program
* re-transplantation for the third or further time
* significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mucoviscidosis, Zollinger-Ellison-syndrome
* history of inflammatory bowel disease: Crohn's disease, ulcerative colitis
* previous gastrectomy, small bowel or large bowel resection, intestinal bypass surgery
* severe liver disease: cirrhosis
* HIV positive

Answer: D