Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Cross-over, Double-blind, Placebo-controlled Study to Assess the Antiproteinuric Effect of Selective Vitamin d Receptor Activation by Paricalcitol in Type 2 Diabetes Patients on Low or High Sodium Diet and Stable Ras Inhibitor Therapy
Brief Summary: Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for renal disease progression. More proteinuria is associated with faster progression, whereas treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower is the disease progression in the long term. On the basis of the above findings, proteinuria has become a target of renoprotective therapy.

Among different antihypertensive medications, those that inhibit the Renin Angiotensin System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce proteinuria and slow renal disease progression. Thus they have become the key component of renoprotective therapy in patients with proteinuric chronic kidney disease. Observational studies found that their effectiveness, however, is limited or even fully blunted in patients who eat large amount of salt.

Experimental evidence indicates a renoprotective role of the vitamin D system in chronic renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor therapy. This effect, however, was largely restricted to subjects with daily sodium intake exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with paricalcitol appears to be effective in particular in those patients who do not appreciably benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake. Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is worth investigating.

The broad aim of this study is to evaluate the interaction between paricalcitol therapy and sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable background RAS inhibitor therapy.


Options:
A: Inclusion Criteria:

* Patients who have received a kidney transplant ≥ 6 months previously who have a BP \>130 mm Hg systolic and/or \>80 mm Hg diastolic, or are receiving treatment for hypertension.

Exclusion Criteria:

* BP \< 120/80 on blood pressure treatment
* BP \>160/100
* Variation in Creatinine \>20% over preceding 2 months
* Secondary hypertension due to a cause other than CKD
* Heart failure (LVEF \<30% or NYHA class II - IV)
* Myocardial Infarction within 6 months
* Stroke within 6 months
* Current diagnosis of cancer
* Liver disease
* Bilateral arterio-venous fistulae
* Evidence of significant active infection
* Females who are pregnant or breastfeeding
* Hyponatremia (Na \<130mmol/L) or Hypernatremia (Na \>150mmol/L)
* Histologically confirmed episode of rejection within 6 months
* Steroids dose change in preceding 2 months
* Patients who are not able to give full informed consent
* Initial 24hr urinary sodium \<80mmol/24hrs
B: Inclusion Criteria:

* Male and female patients;
* Age \> 18 years;
* Type 2 diabetes patients on low or high sodium diet and stable RAS inhibitor therapy with the following conditions:

Urinary albumin excretion (UAE) rate \>300mg/24 hours (200 mcg/min); Serum creatinine \<2 mg/dL, PTH ≥ 20 mEq/L and \<110 mEq/L; Calcium and phosphorus levels \< 9.5 mg/dl and \< 5mg/dl, respectively; Controlled BP (systolic/diastolic \<140/90 mmHg) while on stable RAS inhibitor therapy;

- Written informed consent.

Exclusion Criteria:

* Previous Vitamin D or Vitamin D analogs therapy (within 3 months prior to the study entry);
* Evidence of toxicity to Vitamin D;
* History of kidney stones;
* Poorly controlled Diabetes: Hb1Ac \> 12%;
* Therapy with calcitonin, bisphosphonates, cinacalcet, glucocorticoids, immunosuppressive drugs or other drug that may affect calcium or bone metabolism;
* Cancer and any severe systemic disease or clinical condition that may jeopardize data interpretation or completion of the study;
* Any clinically relevant conditions that might affect study participation and/or study results;
* Any contraindication to be exposed to Paricalcitol;
* Pregnancy or lactating;
* Women of childbearing potential without following a scientifically accepted form of contraception;
* Legal incapacity.
C: Inclusion Criteria:

* Disease history
* Prior stroke and/or
* Aged 60 years or over and with uncontrolled high blood pressure (systolic blood pressure \>=140 millimeters of mercury (mmHg) at visit if on blood pressure lowering medication; systolic blood pressure\>=160 millimeters of mercury (mmHg) if not on blood pressure lowering medication)
* Ownership of a phone by the participant or a household member

Exclusion Criteria:

* Participant or family member is using a potassium-sparing diuretic
* Participant or family member is using a potassium supplement
* Participant or family member has serious renal impairment
* Participant or family member has other reason for concern about use of salt substitute
* Participant eats most meals outside the home
* Participant is not expected to live longer than 6 months from the date of assessment as estimated by the village doctor
* Another family member living in the same household has already been included in the study
D: Inclusion Criteria:

* included patients aged ≥ 18 years who had been on hemodialysis for at least 90 days, and were diagnosed with inflammation. Inflammation was defined as C Reactive Protein ≥ 0.7 mg/dL

Exclusion Criteria:

* acute inflammatory processes confirmed by clinical criteria and/or complementary tests
* acute inflammatory diseases
* tuberculosis
* use of antibiotics within the past two months
* chronic inflammatory diseases
* neoplasias
* chronic obstructive pulmonary disease
* use of central venous catheter and positive HIV serology

Answer: B