Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy and Safety of Selective Vitamin D Receptor Activation With Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients: a Randomized Controlled Trial
Brief Summary: The study 'Safety and Efficacy of Paricalcitol for Reduction of Proteinuria in Kidney Transplant Recipients' is designed to assess the effects of paricalcitol in kidney transplant recipients with proteinuria.

It is a single centre, randomized, placebo-controlled, double-blind clinical trial that tests the hypothesis that 24 weeks' treatment with paricalcitol compared to placebo will result in a decrease in urinary protein excretion in recipients of a kidney transplant at least three months after transplantation. Additionally, the effects of paricalcitol on albuminuria, estimated glomerular filtration rate, and blood pressure will be investigated.


Options:
A: 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).
B: Inclusion Criteria:

* Recipients of a deceased donor kidney transplant at least 3 months after transplantation
* Urinary protein to creatinine ratio (UPCR) \> 200 mg/g (20 mg/mmol) as determined by the the mean of three second morning void urine specimens
* Subject is on stable immunosuppression for at least 3 months
* Subject is on stable doses of antihypertensive medications for at least 3 months
* Subject is not expected to begin dialysis for at least 6 months
* Estimated glomerular filtration rate \> 15 ml/min/1.73 m2
* Corrected serum calcium level \< 2.6 mmol/l
* Intact parathormone value \> 30 pg/ml

Exclusion Criteria:

* Subjects on vitamin D receptor activation therapy within 3 months prior to the first study visit
* Acute kidney injury within 3 months of the first study visit
* Subjects with poorly controlled hypertension
C: 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
D: The key inclusion criteria are:

1. Male or female adult de novo kidney, kidney-pancreas or kidney-islet, or kidney-liver transplant recipients
2. Functioning graft within 28 days after transplantation (creatinine having decreased to \<200 micromol/l without the need for dialysis)
3. Being on standard triple immunosuppression including a calcineurin antagonist (cyclosporine or tacrolimus), mycophenolate (MMF or MPA) and steroids, with or without induction treatment with basiliximab or anti-thymocyte globulin

Key exclusion criteria are:

1. Age \<18 years
2. Rising creatinine after initial drop \<200 micromol/l or creatinine \>200 micromol/l at baseline
3. Evidence of early acute rejection, either suspected clinically and/or proven by biopsy
4. Presence of severe osteoporosis as evidenced by a T score \<-4 at the hip, femoral neck or any of the 4 vertebrae L1 to L4
5. Evidence of severe hyper- or hypoparathyroidism (iPTH \>800 ng/l or \<10 ng/l)
6. Hypocalcemia (total calcium \<1.8 mmol/l) or hypercalcemia (total calcium \>2.7 mmol/l)
7. Steroid-free de novo immunosuppression scheme

Answer: B