Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Very Low Protein Diet Supplemented With Ketoanalogs on Renal Death in Phase 4/5 Chronic Kidney Disease (CKD) - ERIKA Study
Brief Summary: The purpose of this study is to determine whether the use of a very low protein diet is effective in delaying the start of chronic dialysis treatment in patients affected by chronic kidney disease (CKD).


Options:
A: Inclusion Criteria:

* adult non-diabetic patients
* stage 4-5 CKD not on dialysis (estimated glomerular filtration by Modification of Diet in Renal Disease formula \< 30 mL/min per year
* stable renal function at least 12 weeks before enrollment
* well-controlled arterial blood pressure
* proteinuria less than 1 g/g urinary creatinine
* good nutritional status
* declared and anticipated good compliance with the prescribed diet

Exclusion Criteria:

* poorly controlled arterial blood pressure (≥145/85 mm Hg)
* relevant comorbid conditions (diabetes mellitus, heart failure, active hepatic disease, digestive diseases with malabsorption, inflammation/anti-inflammatory therapy)
* uremic complications (pericarditis, polyneuropathy)
* feeding inability (anorexia, nausea)
B: Inclusion Criteria:

* Type 2 diabetes mellitus
* Urinary protein excretion 1-10 g/day
* Serum Cr \<2.0 mg/dl
* With diabetic retinopathy \> SDR
* Normal protein intake instruction
* Patients whose consent is obtained at \>20 or age =\<65

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Non-diabetic nephropathy
* Urinary tract infection
* Congestive heart failure
* Unstable angina
* Myocardial infarction
* Stroke
* Severe hepatopathy
* Life threatening disease such as malignant tumor
* Patients on ACE-I and or ARB treatment
* Patients on instruction of low protein diet
* BW\< 80% of IBW
* Pregnant, lactating, and probably pregnant patients
* Patients judged as being inappropriate fir the subjects
C: Inclusion Criteria:

* Patients with chronic renal insufficiency in stage CKD 4 and 5 (GFR \< 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance) receiving conservative treatment for CKD
* Incident patients with chronic renal insufficiency in stage CKD 4 and 5 (GFR \< 30 ml/min/1.73m2, estimated by the 24-hours creatinine clearance), provided stable renal function determined by two 24-hour measurements of creatinine clearance 2 weeks a part

Exclusion Criteria:

* Patients already on very low protein diet
* Change of creatinine clearance \> 30% within the last 3 months
* Severe undernutrition as indicated by :

  1. BMI \< 20 kg/m2 in presence of serum albumin \< 3.0 g/dl, or BMI \< 17.5 kg/m2 whatever albumin value
  2. body weight reduction \> 7.5% within the last 3 months
* Severe obesity as indicated by BMI \> 35 kg/m2
* Pregnancy or feeding
* Chronic treatment with steroid or cytotoxic drugs
* Fast progressing glomerulonephritis
* Active SLE and vasculitis
* Cardiac failure stage IV NYHA
* Advanced liver cirrhosis
* Active cancer diseases
* Severe encephalopathy associated with lack of spontaneous feeding
* Chronic obstructive respiratory diseases needing oxygen treatment
D: Inclusion Criteria:

* Type 2 diabetes
* Microalbuminuria

Exclusion Criteria:

* Stimulated serum C-peptide concentration less than 600 pmol/L
* Pancreatic insufficiency or diabetes secondary to pancreatitis
* Alcohol abuse
* Non-diabetic kidney disease
* Life-threatening disease with death probable within 4 years of study start

Answer: C