The Effect of Paricalcitol Capsules on Reducing Albuminur... | NCT00421733

ID	Type	Description	Link
2006-001363-31	EudraCT Number

Label	Type	Description	Intervention Names
Paricalcitol 1 mcg	Active Comparator	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	Drug: Zemplar (paricalcitol ) capsules
Paricalcitol 2 mcg	Active Comparator	Two paricalcitol 1 mcg capsules per dose	Drug: Zemplar (paricalcitol) capsules
Placebo	Placebo Comparator	Two placebo capsules per dose	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Zemplar (paricalcitol ) capsules	Drug	Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)	Paricalcitol 1 mcg

Measure	Description	Time Frame
Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).	UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.	Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

Measure	Description	Time Frame
Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.	Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.	Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participant >= 20 years old.
Participant has Type 2 Diabetes Mellitus and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Phase
Participant has been receiving a stable dose (i.e., same type and regimen) of ACEi and/or ARB for at least three months prior to the Screening Phase. However, participant may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.
Participant is not expected to begin dialysis for at least 6 months.
If female, participant is not breast feeding or is not pregnant.
For entry into the Treatment Phase, the participant must satisfy the following criteria based on the Screening laboratory values:
- Estimated glomerular filtration rate (GFR) between 15-90 mL/min/1.73m2 by simplified Modification in Diet in Renal Disease (MDRD) formula
- Urinary albumin to creatinine ratio (UACR) between 100 and 3000 mg/g as determined by the mean of the three first morning void urine specimens obtained within one week of each other
- Corrected serum calcium level <= 9.8 mg/dL
- intact parathyroid hormone (iPTH) value between 35-500 pg/mL
- Glycosylated hemoglobin A1c (HbA1c) <= 12%
- Serum albumin > 3.0 g/dL
- Negative urine pregnancy test for female participants

Exclusion Criteria:

Participant has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase.
Participant has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
Participant has primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy.
Participant has had acute renal failure within 12 weeks of the Screening Phase, defined as an acute rise (of >= 0.5 mg/dL) in serum creatinine to > 4 mg/dL.
Participant has chronic gastrointestinal disease.
Participant has secondary hypertension.
Participant has poorly controlled hypertension.
Participant has a history of kidney stones.
Participant has a history of drug or alcohol abuse within six months prior to the Screening Phase.
Participant has evidence of poor compliance with diet or medication.
Participant has received any investigational drug within 30 days prior to study drug administration.
Participant is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical glucocorticoids), or other drugs that may affect calcium, or bone metabolism, other than calcium containing phosphate binder or female participants on stable (same dose and product for three months) estrogen and/or progestin therapy.
For any reason, participant is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
Participant is known to be human immunodeficiency virus (HIV) positive.
Participant has used known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration.

Name	Affiliation	Role
Dennis Andress, MD	Abbott	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 862		Phoenix	Arizona	85012	United States
Site Reference ID/Investigator# 864

PubMed Identifier	Type	Citation	Retractions
23787544	Derived	Coyne DW, Andress DL, Amdahl MJ, Ritz E, de Zeeuw D. Effects of paricalcitol on calcium and phosphate metabolism and markers of bone health in patients with diabetic nephropathy: results of the VITAL study. Nephrol Dial Transplant. 2013 Sep;28(9):2260-8. doi: 10.1093/ndt/gft227. Epub 2013 Jun 19.
21055801	Derived

ID	Title	Description
FG000	Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
FG001	Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).

UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.

Intent-to-treat population, which was all randomized participants who received at least 1 dose of study drug. Subjects without both a baseline and last on-treatment measurement were excluded from the primary efficacy analysis. As such, sample size was N=88 for placebo, N=92 for 1 mcg and for 2 mcg paricalcitol, and N=184 for combined paricalcitol.

Posted

Mean

Standard Deviation

log milligram/gram creatinine

Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

ID	Title	Description
OG000	Placebo	Two placebo capsules per dose (N=88)
OG001	Combined Paricalcitol 1 Mcg and 2 Mcg	Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).
OG002	Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
OG003	Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose

Units	Counts
Participants	OG00088 OG001184 OG00292 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-0.03± 0.61 OG001-0.18± 0.70 OG002-0.15± 0.72 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA	1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.	0.071	There were no P-value adjustments for multiple comparisons.												No	Superiority or Other
OG000 OG002		ANCOVA

Secondary

Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.

Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.

Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline measurement and a last on-treatment visit value were excluded from the analyses.

Posted

Number

Participants

Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

ID	Title	Description
OG000	Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
OG001	Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose
OG002	Placebo	Two placebo capsules per dose

Secondary

Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.

The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.

Posted

Mean

Standard Deviation

log milligrams of albumin per 24 hours

Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

ID	Title	Description
OG000	Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
OG001	Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose
OG002	Placebo	Two placebo capsules per dose

Secondary

Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.

Change is mean change in picograms of iPTH per milliliter of serum.

Intent-to-treat population, which was all randomized subjects who received at least one dose of study drug. Subjects who did not have both a baseline and a last on-treatment measurement were excluded from the analyses.

Posted

Mean

Standard Deviation

picogram/milliliter

Baseline (screening period) through 24 weeks of treatment

ID	Title	Description
OG000	Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
OG001	Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose
OG002	Placebo	Two placebo capsules per dose

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0021 affected93 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0012 affected95 at risk EG0020 affected93 at risk
Angina pectoris	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Atrial flutter	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Bradycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0021 affected93 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Coronary artery disease	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Gastrointestinal angiodysplasia haemorrhagic	Congenital, familial and genetic disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Cataract	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Retinal oedema	Eye disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk
Gastritis	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0022 affected93 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0021 affected93 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0021 affected93 at risk
Asthenia	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Death	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Impaired healing	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk
Non-cardiac chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk
Bacteraemia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Cellulitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0021 affected93 at risk
Pneumonia	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Posteroperative wound infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk
Respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk
Sepsis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Blood pressure increased	Investigations	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0012 affected95 at risk EG0020 affected93 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Benign colonic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk
Oesophageal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0012 affected95 at risk EG0020 affected93 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Nervousness	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Substance abuse	Psychiatric disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Renal failure	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0012 affected95 at risk EG0021 affected93 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0021 affected93 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0021 affected93 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0020 affected93 at risk
Extremity necrosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Hypertensive crisis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0010 affected95 at risk EG0020 affected93 at risk
Hypotension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0012 affected95 at risk EG0020 affected93 at risk
Thrombosis	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0021 affected93 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected93 at risk EG0018 affected95 at risk EG0025 affected93 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected93 at risk EG0012 affected95 at risk EG0021 affected93 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected93 at risk EG0011 affected95 at risk EG0026 affected93 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected93 at risk EG0012 affected95 at risk EG0024 affected93 at risk
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0023 affected93 at risk
Fatigue	General disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0015 affected95 at risk EG0021 affected93 at risk
Oedema	General disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected93 at risk EG0013 affected95 at risk EG0021 affected93 at risk
Oedema peripheral	General disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected93 at risk EG0014 affected95 at risk EG0024 affected93 at risk
Pyrexia	General disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0023 affected93 at risk
Bronchitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0003 affected93 at risk EG0012 affected95 at risk EG0021 affected93 at risk
Nasopharyngitis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected93 at risk EG0013 affected95 at risk EG0022 affected93 at risk
Tinea pedis	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0010 affected95 at risk EG0023 affected93 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0005 affected93 at risk EG0015 affected95 at risk EG0024 affected93 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.0	Systematic Assessment	EG0002 affected93 at risk EG0016 affected95 at risk EG0022 affected93 at risk
Blood parathyroid hormone decreased	Investigations	MedDRA 12.0	Systematic Assessment	EG0002 affected93 at risk EG0013 affected95 at risk EG0020 affected93 at risk
Gout	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0011 affected95 at risk EG0023 affected93 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0012 affected95 at risk EG0023 affected93 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected93 at risk EG0015 affected95 at risk EG0024 affected93 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected93 at risk EG0013 affected95 at risk EG0024 affected93 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0001 affected93 at risk EG0014 affected95 at risk EG0022 affected93 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0011 affected95 at risk EG0025 affected93 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0002 affected93 at risk EG0013 affected95 at risk EG0020 affected93 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 12.0	Systematic Assessment	EG0004 affected93 at risk EG0012 affected95 at risk EG0023 affected93 at risk
Dizziness	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0003 affected93 at risk EG0013 affected95 at risk EG0021 affected93 at risk
Headache	Nervous system disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0013 affected95 at risk EG0024 affected93 at risk
Chronic obstructive pulmonsry disease	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0000 affected93 at risk EG0013 affected95 at risk EG0020 affected93 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected93 at risk EG0010 affected95 at risk EG0023 affected93 at risk
Hypertension	Vascular disorders	MedDRA 12.0	Systematic Assessment	EG0005 affected93 at risk EG0018 affected95 at risk EG00211 affected93 at risk

ID	Term
D003928	Diabetic Nephropathies
D051436	Renal Insufficiency, Chronic

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases
D051437	Renal Insufficiency
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

ID	Title	Description
BG000	Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
BG001	Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose
BG002	Placebo	Two placebo capsules per dose
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Paricalcitol 1 Mcg	One paricalcitol 1 mcg capsule and one matching placebo capsule per dose	13	93	38	93
EG001	Paricalcitol 2 Mcg	Two paricalcitol 1 mcg capsules per dose	19	95	46	95
EG002	Placebo	Two placebo capsules per dose	12	93	46	93