anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Erythromycin
Trial phase: Phase 2 | Phase 3
ATC code: D10AF02 | D10AF52 | J01FA01 | S01AA17
SMILES: CC[C@H]1OC(=O)[C@H](C)[C@@H](O[C@H]2C[C@@](C)(OC)[C@@H](O)[C@H](C)O2)[C@H](C)[C@@H](O[C@@H]2O[C@H](C)C[C@H](N(C)C)[C@H]2O)[C@](C)(O)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@]1(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Erythromycin 200 mg i.v. suspension
Eligibility criteria:
Inclusion Criteria:

Normal healthy adult volunteers without known gastrointestinal disease
Aged 18-70 years
Able to provide written informed consent before participating in the study
Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

Known allergy to erythromycin;
Use of drugs that have known contraindication with erythromycin (concomitant therapy with astemizole, cisapride, pimozide, or terfenadine)
Corrected QT interval on EKG >460 msec
Certain medications (i.e., theophylline, digoxin, oral anti-coagulant, benzodiazepine, 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors) will either be excluded from the study or, if medically safe, will be asked to discontinue the medication for 4 half-lives before beginning the study.
Use of medications that alter GI motility e.g., narcotics, medications with significant anticholinergic effects
Pregnant or breast-feeding females
Known claustrophobia
Known family history of sudden death or congenital QT prolongation
Presence of pacemaker, internal defibrillator, or other non-MR compatible device
Patients with known metal present within their abdomen
Intervention: Triheptanoin
Trial phase: Phase 2
ATC code: A16AX17
SMILES: CCCCCCC(=O)OCC(COC(=O)CCCCCC)OC(=O)CCCCCC
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Subjects randomized to consume 20% of energy from MCT

Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of Very long-chain acylCoA dehydrogenase (VLCAD) Deficiency, Carnitine Palmitoyltransferase 2 (CPT2) Deficiency, Mitochondrial Trifunctional Protein (TFP) Deficiency, or Long-chain 3 hydroxyacylCoA dehydrogenase (LCHAD) deficiency
> 7 years
Ability to travel to CRC to participate
Ability to follow protocol

Exclusion Criteria:

Hgb < 10 g/dl
Peripheral neuropathy that limits ability to complete treadmill studies
Inclusion in another research study that alters macronutrient intake
Pregnant females
history of myocardial infarction or cardiovascular disease
Intervention: Triheptanoin
Trial phase: Phase 2
ATC code: A16AX17
SMILES: CCCCCCC(=O)OCC(COC(=O)CCCCCC)OC(=O)CCCCCC
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Subject randomized to consume 20% of energy from triheptanoin.

Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of Very long-chain acylCoA dehydrogenase (VLCAD) Deficiency, Carnitine Palmitoyltransferase 2 (CPT2) Deficiency, Mitochondrial Trifunctional Protein (TFP) Deficiency, or Long-chain 3 hydroxyacylCoA dehydrogenase (LCHAD) deficiency
> 7 years
Ability to travel to CRC to participate
Ability to follow protocol

Exclusion Criteria:

Hgb < 10 g/dl
Peripheral neuropathy that limits ability to complete treadmill studies
Inclusion in another research study that alters macronutrient intake
Pregnant females
history of myocardial infarction or cardiovascular disease
Intervention: Isoflurane
Trial phase: Not Applicable
ATC code: N01AB06
SMILES: FC(F)OC(Cl)C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1584
Group description: Isoflurane is to be administered to patients in this arm during surgery

Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Eligibility criteria:
Inclusion Criteria:

Must have surgery in G operating room suite
Intervention: Sevoflurane
Trial phase: Not Applicable
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1584
Group description: Sevoflurane is to be administered to patients in this arm during surgery

Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Eligibility criteria:
Inclusion Criteria:

Must have surgery in G operating room suite
Intervention: Morphine
Trial phase: Phase 3
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis

Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.

Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
Eligibility criteria:
Inclusion Criteria:

Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes
6 years old and < 19 years old
Normal baseline chest radiograph
Normal renal and hepatic function within the previous 12 months

Exclusion Criteria:

Previous patient participation in this clinical trial
Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest radiograph on admission
Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or off treatment
Any patient with documented allergy to either study drug

Any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as:

Hepatic dysfunction (3x ALT),
Renal dysfunction (Cr > 1 children/adolescents, Cr >2 adults),
Pulmonary Hypertension (TRJ >3.0),
Cardiac dysfunction.
Any patient with symptoms of an acute stroke.
Any patient known or suspected to be pregnant.
Any patient with priapism
The patient or guardian who will not give consent or assent to be randomized.
Intervention: Nalbuphine Hydrochloride
Trial phase: Phase 3
SMILES: Cl.Oc1ccc2c3c1OC1C(O)CCC4(O)C(C2)N(CC2CCC2)CCC314
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients

Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.

Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
Eligibility criteria:
Inclusion Criteria:

Patients with sickle cell disease (SS, SC, SβThal) who are hospitalized for acute painful episodes
6 years old and < 19 years old
Normal baseline chest radiograph
Normal renal and hepatic function within the previous 12 months

Exclusion Criteria:

Previous patient participation in this clinical trial
Any patient on chronic transfusion Any patient with pulmonary infiltrate on chest radiograph on admission
Any patient with DSM diagnosis, excluding those with Attention Deficit Disorder, on or off treatment
Any patient with documented allergy to either study drug

Any patient with known evidence of an underlying disease that would interfere with evaluation of a therapeutic response such as:

Hepatic dysfunction (3x ALT),
Renal dysfunction (Cr > 1 children/adolescents, Cr >2 adults),
Pulmonary Hypertension (TRJ >3.0),
Cardiac dysfunction.
Any patient with symptoms of an acute stroke.
Any patient known or suspected to be pregnant.
Any patient with priapism
The patient or guardian who will not give consent or assent to be randomized.
Intervention: Vadadustat
Trial phase: Phase 2
ATC code: B03XA08
SMILES: O=C(O)CNC(=O)c1ncc(-c2cccc(Cl)c2)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Participants with anemia secondary to chronic kidney disease (CKD), stages 3 and 4 were administered with an oral dose of AKB-6548 240 milligrams (mg) capsule once daily (QD) for 42 days.
Eligibility criteria:
Key Inclusion Criteria:

18 to 79 years of age, inclusive
Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis
Hemoglobin (Hgb) ≤ 10.5 g/dL
Transferring saturation ≥ 20%
Ferritin ≥ 50 ng/mL

Key Exclusion Criteria:

Body mass index >42
Red blood cell transfusion within 12 weeks
Androgen therapy within the previous 21 days prior to study dosing
Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 11 weeks prior to the Screening visit
Participants meeting the criteria of ESA resistance within the previous 4 months
Individual doses of intravenous iron of greater than 250 mg within the past 21 days
Aspartate aminotransferase or alanine aminotransferase >1.8x upper limit of normal (ULN)
Alkaline phosphatase >2x ULN
Total bilirubin >1.5x ULN
Uncontrolled hypertension
New York Heart Association Class III or IV congestive heart failure
Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing
Intervention: Vadadustat
Trial phase: Phase 2
ATC code: B03XA08
SMILES: O=C(O)CNC(=O)c1ncc(-c2cccc(Cl)c2)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 370 mg capsule QD for 42 days.
Eligibility criteria:
Key Inclusion Criteria:

18 to 79 years of age, inclusive
Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis
Hemoglobin (Hgb) ≤ 10.5 g/dL
Transferring saturation ≥ 20%
Ferritin ≥ 50 ng/mL

Key Exclusion Criteria:

Body mass index >42
Red blood cell transfusion within 12 weeks
Androgen therapy within the previous 21 days prior to study dosing
Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 11 weeks prior to the Screening visit
Participants meeting the criteria of ESA resistance within the previous 4 months
Individual doses of intravenous iron of greater than 250 mg within the past 21 days
Aspartate aminotransferase or alanine aminotransferase >1.8x upper limit of normal (ULN)
Alkaline phosphatase >2x ULN
Total bilirubin >1.5x ULN
Uncontrolled hypertension
New York Heart Association Class III or IV congestive heart failure
Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing
Intervention: Vadadustat
Trial phase: Phase 2
ATC code: B03XA08
SMILES: O=C(O)CNC(=O)c1ncc(-c2cccc(Cl)c2)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Participants with anemia secondary to CKD, stages 3 and 4 were administered with an oral dose of AKB-6548 630 mg capsule QD for 42 days.
Eligibility criteria:
Key Inclusion Criteria:

18 to 79 years of age, inclusive
Chronic Kidney Disease (eGFR <60 mL/min), not yet on dialysis
Hemoglobin (Hgb) ≤ 10.5 g/dL
Transferring saturation ≥ 20%
Ferritin ≥ 50 ng/mL

Key Exclusion Criteria:

Body mass index >42
Red blood cell transfusion within 12 weeks
Androgen therapy within the previous 21 days prior to study dosing
Therapy with any approved or experimental erythropoiesis stimulating agent (ESA) within the 11 weeks prior to the Screening visit
Participants meeting the criteria of ESA resistance within the previous 4 months
Individual doses of intravenous iron of greater than 250 mg within the past 21 days
Aspartate aminotransferase or alanine aminotransferase >1.8x upper limit of normal (ULN)
Alkaline phosphatase >2x ULN
Total bilirubin >1.5x ULN
Uncontrolled hypertension
New York Heart Association Class III or IV congestive heart failure
Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to dosing
Intervention: Paricalcitol
Trial phase: Phase 3
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 13
Group description: Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening
Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism

For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor [VDR] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment:

A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL
A phosphorus value ≤ 6.5 mg/dL
An intact parathyroid hormone (iPTH) value > 300 pg/mL and less ≤ 2000 pg/mL

Exclusion Criteria:

Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy
Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion)
Subject has had a parathyroidectomy within 12 weeks prior to Screening
Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening
Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing
Subject is receiving cinacalcet at the time of Screening
Intervention: Pentoxifylline
Trial phase: Phase 4
ATC code: C04AD03 | R03DA20
SMILES: CC(=O)CCCCn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Pentoxifylline 400mg three times a day

Pentoxifylline: Pentoxifylline 400mg three times a day
Eligibility criteria:
Inclusion Criteria:

type 2 diabetes mellitus
age >=20 years
spot urine albumin/creatinine ratio > 30mg/g in two consecutive measurements
patients on ACE-inhibitor or ARB as an anti-hypertensive drug
blood pressure <= 150/100 mmHg
HbA1c <10%

Exclusion Criteria:

taking insulin pentoxifylline, cilostazol, ketas, viagra in 3 months
ischemic heart disease, stroke, malignant disease, severe infection in 6 months
serum creatinine > 2.0mg/dl
severe liver disease or AST, ALT > 3* ULM
taking systemic steroid in 1 month
pregnant or plan to become pregnant during the clinical trial
lactation
Intervention: CID 12303048
Trial phase: Not Applicable
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
Eligibility criteria:
Inclusion Criteria:

Adults admitted to ICUs located in Tower Two Critical Care Units: Medical, Surgical, Medical #2, and Trauma Intensive Care Units.
Patients will be randomized to either treatment or standard group based on day of admission to Intensive Care Units. No limitation regarding gender, race, and ethnicity so that the sample will reflect "typical" Trauma population.

Exclusion Criteria:

All patients admitted under "Doe" Status
All patients with acute cervical spine injuries or facial fractures that oral care will create further harm to the patient (physician order stating "no oral care to be given" will be in chart)
All patients with Oral Trauma or Oral Surgery
All minors (Study will be completed in Adult Critical Care Units)
Patients with allergy to chlorhexidine
Patients without Teeth, or with fewer than 6 teeth
Intervention: Curcumin
Trial phase: Phase 2
SMILES: COc1cc(/C=C/C(=O)CC(=O)/C=C/c2ccc(O)c(OC)c2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Theracurmin (180mg/day)

Curcumin: Six capsules (containing 30 mg of curcumin each) per day for 18 months.
Eligibility criteria:
Inclusion Criteria

Agreement to participate in the 18-month double-blind, placebo-controlled clinical trial of curcumin.
Diagnostic criteria for mild cognitive impairment (MCI) or any age related memory decline according to standard criteria (Petersen et al, 2001; Crook et al, 1986).
Age 50 to 90 years.
No significant cerebrovascular disease: modified Ischemic Score of < 4 (Rosen et al, 1980).
Adequate visual and auditory acuity to allow neuropsychological testing.
Screening laboratory tests and EKG without significant abnormalities that might interfere with the study.

Exclusion Criteria

Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal) (McKhann et al, 1984).
Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of stroke, TIA, carotid bruits, or lacunes on MRI scans will be excluded.
Inability to undergo MRI.
Evidence of Parkinson's disease as determined by the motor examination (items 18-31) of the Unified Parkinson's Disease Rating Scale (Fahn et al, 1987).
History of myocardial infarction within the previous year, or unstable cardiac disease.
Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100).
History of significant liver disease, clinically-significant pulmonary disease, diabetes, or cancer.
Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000).
Current diagnosis or history of alcoholism or substance addiction.
Regular use of any medication that may affect cognitive functioning including: centrally active beta-blockers, narcotics, Clonidine, anti-Parkinsonian medications, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, or Warfarin. Occasional chloral hydrate use will be allowed, but discouraged, for insomnia.
Use of more than one multivitamin per day. Vitamins other than the standard multivitamin supplement will not be allowed.
Use of medications known to affect FDDNP-PET binding (e.g., ibuprofen, naproxen).
Use of more than one daily baby aspirin (81mg) and/or use of any medication containing curcumin.
Use of cognitive enhancing supplements (e.g. Ginkgo biloba).
Use of any investigational drugs within the previous month or longer, depending on drug half-life.
Pregnancy.
HIV infection.
Evidence of vasogenic edema; specifically, evidence of more than 4 cerebral microhemorrhages (regardless of their anatomical location or diagnostic characterization as "possible" or "definite") or a single area of superficial siderosis), or evidence of a prior macrohemorrhage at screening or baseline.
Intervention: Diclofenac
Trial phase: Phase 4
ATC code: D11AX18 | M01AB05 | M01AB55 | M02AA15 | S01BC03 | S01CC01
SMILES: O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
Eligibility criteria:
Inclusion Criteria:

Ages 20-75
Unilateral or bilateral knee osteoarthritis (OA), confirmed radiographically.
Patients taking oral non-steroidal anti-inflammatory drugs (NSAIDs) in the amount and schedule prior to the breakthrough period will be permitted.

Exclusion Criteria:

Patients with clinical history of anterior cruciate ligament (ACL) involvement.
Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)
History of ulcers or gastrointestinal (GI) bleeding
Coagulation disorders
Hypersensitivity to Aspirin or NSAIDS
Congestive Heart Failure and Edema
Advanced renal disease
Aspirin triad
Pregnant women
Intervention: Cholecalciferol
Trial phase: Phase 3
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Cholecalciferol 4000 IU capsule by mouth daily x 1 month then 2000 IU capsule by mouth daily x 5 months

Cholecalciferol
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated Glomerular Filtration Rate [GFR] 44-15 ml/min/1.73m2)
Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level < 30 ng/mL
Corrected serum calcium < 10.2 mg/dL
Serum phosphate < 4.6 mg/dL
Serum albumin > 3.0 g/dL
Body mass index < 40 kg/m2
Ability to give informed consent

Exclusion Criteria:

Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
Expected to undergo living related kidney transplant in next 6 months
Pregnant, breastfeeding, or unwilling to use adequate birth control
History of severe liver disease
Nephrotic range proteinuria (> 3.5 gm/day)
Use of active vitamin D analogs within 30 days of randomization
Intervention: Calcitriol
Trial phase: Phase 3
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Calcitriol 0.25 mcg capsule by mouth daily x 1 month then 0.5 mcg capsule by mouth daily x 5 months

Calcitriol
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
Chronic kidney disease stage IIIB or IV by 4 parameter Modified Diet in Renal Diseases Formula (Estimated Glomerular Filtration Rate [GFR] 44-15 ml/min/1.73m2)
Vitamin D (D2 + D3) deficient, defined as serum 25(OH)D level < 30 ng/mL
Corrected serum calcium < 10.2 mg/dL
Serum phosphate < 4.6 mg/dL
Serum albumin > 3.0 g/dL
Body mass index < 40 kg/m2
Ability to give informed consent

Exclusion Criteria:

Significant co-morbid conditions that lead the investigator to conclude that life expectancy is less than 1 year
Expected to undergo living related kidney transplant in next 6 months
Pregnant, breastfeeding, or unwilling to use adequate birth control
History of severe liver disease
Nephrotic range proteinuria (> 3.5 gm/day)
Use of active vitamin D analogs within 30 days of randomization