Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prospective Double Blind Multicentre Randomized Trial of Vitamine D Estimating the Profit of a Treatment by Vitamin D3 at the Dose of 100000 UI by Comparison With a Treatment in the Dose of 12 000 UI at Renal Transplanted Patients
Brief Summary: It has been proposed that the intake of high dose of cholecalciferol may have beneficial non classical effects (beside bone health). This could include the reduction of type 2 diabetes mellitus, cardiovascular diseases, cancers, autoimmune and infectious diseases. These pleiotropic effects are mostly documented by observational and experimental studies or small intervention trials. In renal transplant recipients, vitamin D insufficiency, defined as circulating 25(OH)vitamin D (25OHD) less than 30 ng/mL, is a frequent finding and this population is at risk of the previously cited complications.The primary purpose of this study is to compare the effects of high dose vs. low dose of cholecalciferol on a composite endpoint consisting in de novo diabetes mellitus, cardiovascular diseases, de novo cancer and patient death.Renal transplant recipients between 12 and 48 months after transplantation will be randomized to blindly receive either high or low dose of cholecalciferol with a follow-up of 2 years.


Options:
A: Inclusion Criteria:

* Renal transplant recipients between 12 and 48 months after transplantation with a stable renal function during the past 3 months.
* Vitamine D insufficiency defined as a concentration of 25OHD lower than 30 ng/ml.
* Patient between 18 and 75 years old
* Patient capable of understanding the advantages and the risks of the study.
* Affiliated with social security health insurance
* Written informed consent

Exclusion Criteria:

* Calcaemia \> 2,7 mmol/l
* Phosphataemia \> 1,5 mmol/l
* Serum creatinine \> 250 µmol/l
* Treatment by an active form of the vitamin D not being able to be interrupted
* Transplant of an organ other than the kidney
* Type I or type II diabetes mellitus
* Past medical history of granulomatosis or active granulomatosis
* Primary hyperoxaluria
* Malabsorption proved by the liposoluble vitamins
* Simultaneous participation in another therapeutic essay
* Patients presenting a drug addiction or a psychiatric disorder
* Pregnant or breast-feeding women
* Vitamin D hyper sensibility
B: 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
C: 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.
D: 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).

Answer: A