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Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients

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ClinicalTrials.gov Identifier: NCT01265615
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : June 21, 2011
Last Update Posted : June 9, 2015
Sponsor:
Collaborators:
Ural Institute of Cardiology
De Haar Research Foundation
Information provided by (Responsible Party):
Alexander Kharlamov, Ural Medical University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Cardiorenal Syndrome
Chronic Allograft Nephropathy
Interventions Drug: Paricalcitol
Drug: Calcitriol
Drug: Cholecalciferol
Dietary Supplement: Supplemental
Enrollment 109
Recruitment Details A total of 120 patients (Russian and dutch caucasian, kidney recipients with vitamin D deficiency defined as 25(OH)D < 30 ng/mL) were assigned on the basis of Ural Institute of Cardiology. Nine of the 120 patients were subsequently excluded due to protocol violation. All the patients had given their written informed consents.
Pre-assignment Details  
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description 6-8 μg daily per os without special diet 2-4 μg daily orally under with dietary restrictions of vitamin D alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Period Title: Overall Study
Started 30 30 30 30
Completed 28 28 26 27
Not Completed 2 2 4 3
Reason Not Completed
Protocol Violation             2             2             4             3
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental Total
Hide Arm/Group Description 6-8 μg daily per os without special diet 2-4 μg daily orally under with dietary restrictions of vitamin D alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day Total of all reporting groups
Overall Number of Baseline Participants 30 30 30 30 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 30 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
28
  93.3%
28
  93.3%
26
  86.7%
27
  90.0%
109
  90.8%
>=65 years
2
   6.7%
2
   6.7%
4
  13.3%
3
  10.0%
11
   9.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 30 participants 30 participants 120 participants
56  (4) 59  (4) 58  (5) 57  (4) 58  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 30 participants 30 participants 120 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
30
 100.0%
30
 100.0%
30
 100.0%
30
 100.0%
120
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Russian Federation Number Analyzed 30 participants 30 participants 30 participants 30 participants 120 participants
30 30 30 30 120
1.Primary Outcome
Title CAD (Chronic Allograft Dysfunction) Degree
Hide Description

Beyond 180 days, chronic allograft dysfunction (CAD) was characterized by mean Banff degree (revised 2005/2007 criteria) with the data of renal biopsy material. Renal tissue was recovered during routined biopsy. We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:

Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26–50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)

Time Frame day 180 after Tx (transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: Scores on a Banff scale
1.24  (0.14) 1.22  (0.42) 1.43  (0.22) 1.68  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title Heart Failure (HF)
Hide Description

NYHA (New York Heart Association) functional class verified with veloergometry probe and by NYHA clinical classification NYHA Class Symptoms I No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.

II Mild symptoms and slight limitation during ordinary activity. III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20–100 m).

Comfortable only at rest. IV Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.

Time Frame on day 180 after Tx (transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 120 patients (Russian and dutch caucasian, kidney recipients with vitamin D deficiency defined as 25(OH)D < 40 nmol/l) were assigned. Analysis was per protocol.
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: NYHA functional class of HF
1.8  (0.2) 1.9  (0.3) 1.9  (0.1) 2.5  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title GFR (Glomerular Filtration Rate)
Hide Description Estimated glomerular filtration rate (eGFR) was calculated using the abbreviated form of the Modification of Diet in Renal Disease (MDRD) study equation: eGFR = exp (5.228 − 1.154 × ln (serum creatinine) − 0.203 × ln (age). Concerning of GFR with Tc99m DTPA renography was used for the complex analysis of renal function. Camera based GFR estimated from Tc99m DTPA renography was named Gates GFR.
Time Frame on day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: ml/min/1.73 m^2
84  (11) 81  (9) 76  (10) 54  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title CAD (Chronic Allograft Dysfunction) Degree
Hide Description

CAD degree measured by Banff score after routine renal biopsy (revised 2005/2007 criteria). We assessed antibody-mediated rejection, borderline changes, T-cell-mediated rejection, interstitial fibrosis and tubular atropthy, and other changes. Grades:

Grade I. Mild interstitial fibrosis and tubular atrophy (<25% of cortical area) II. Moderate (26–50%) III. Severe (>50%) (may include non-specific vascular and glomerular sclerosis)

Time Frame on day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: Scores on a Banff scale
1.24  (0.14) 1.22  (0.42) 1.43  (0.22) 1.68  (0.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Serum Creatinine
Hide Description After an overnight fast, plasma concentrations of hemoglobin, creatinine, cholesterol, glucose, total calcium, and phosphate were measured using an autoanalyzer as described by Adorini L. (2005)
Time Frame on day 180 after Tx
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.5  (0.9) 2.5  (0.7) 2.8  (0.7) 4.1  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Number of Circulating SP (Side Population) Stem-Progenitor Cells
Hide Description Renal cells and solid tissue were obtained from the normal portion of cortex obtained from surgically removed kidneys or by standart biopsy on day 180. Cytofluorimetric analysis and immunofluorescence were performed as described by Oliver J.A. (2004). Sorting and analysis of different cells was done on a FACS (fluorescent activated cell sorting) and by flow cytometry. Cells were analyzed with EPICS systems (Beckman Coulter). Quantification of mRNA expression was achieved using Assays-on-Demand gene expression kits and the ABI PRISM 7000 Sequence Detection System (Applied Biosystem).
Time Frame on day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: per cent of SP cells
7.6  (0.9) 6.5  (1) 5.7  (0.8) 4.2  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title VDR (Vitamin D Receptor) Expression in Myocardium
Hide Description VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.
Time Frame on day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: fmol VDR/ mg protein
801  (112) 715  (96) 654  (88) 389  (77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title VDR (Vitamin D Receptor) Expression in Kidney
Hide Description VDR content was determined by using an ELISA developed in this laboratory. The protein concentration of the homogenates was determined by the method of Bradford (1976), using BSA as a standard.
Time Frame on day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: fmol VDR/ mg protein
584  (103) 599  (102) 478  (79) 333  (62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Systolic Blood Pressure
Hide Description SBP measured by routine method
Time Frame on day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: mmHg
143  (22) 141  (9) 147  (13) 165  (19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Coronary Calcium Score
Hide Description Bone mineral density assessed by dual-energy X-ray absorptiometry (DXA) of the whole body, lumbar spine and hip was performed using Hologic scanners (QDR 1000W or QDR 2000). The total Agatston coronary calcium score (CCS) was measured as the sum of calcified plaque scores of all the coronary arteries. The amount of calcium present in the coronary arteries is scored according to the Agatson scale, as follows: 0 - no identifiable disease; 1 to 99 - mild disease; 100 to 399 - moderate disease; 400 or higher - severe disease.
Time Frame on day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description:
6-8 μg daily per os without special diet
2-4 μg daily orally under with dietary restrictions of vitamin D
alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
Overall Number of Participants Analyzed 28 28 26 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
530  (423) 611  (502) 524  (122) 990  (120)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paricalcitol Treatment, Calcitriol Treatment, Cholecalciferol, Supplemental
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Hide Arm/Group Description 6-8 μg daily per os without special diet 2-4 μg daily orally under with dietary restrictions of vitamin D alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
All-Cause Mortality
Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/30 (30.00%)      21/30 (70.00%)      6/30 (20.00%)      8/30 (26.67%)    
Cardiac disorders         
Myocardial infarction  1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 5/30 (16.67%)  5
Endocrine disorders         
Hypercalcemia  1  2/30 (6.67%)  2 4/30 (13.33%)  4 0/30 (0.00%)  0 0/30 (0.00%)  0
Hypophospatemia  1  7/30 (23.33%)  7 16/30 (53.33%)  16 5/30 (16.67%)  5 1/30 (3.33%)  1
Nervous system disorders         
Stroke  1  0/30 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 2/30 (6.67%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paricalcitol Treatment Calcitriol Treatment Cholecalciferol Supplemental
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/30 (33.33%)      15/30 (50.00%)      9/30 (30.00%)      9/30 (30.00%)    
Cardiac disorders         
Increased hypertension  1  4/30 (13.33%)  4 3/30 (10.00%)  3 5/30 (16.67%)  5 6/30 (20.00%)  6
Hypotension  1  1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Syncope  1  1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Cardiac arrhythmias  1  0/30 (0.00%)  0 3/30 (10.00%)  3 1/30 (3.33%)  1 0/30 (0.00%)  0
Eye disorders         
Conjuctivitis  1  1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Photophobia  1  1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Gastrointestinal disorders         
Abdominal Pain  1  1/30 (3.33%)  1 2/30 (6.67%)  2 1/30 (3.33%)  1 1/30 (3.33%)  1
Diarrhea  1  4/30 (13.33%)  4 5/30 (16.67%)  5 4/30 (13.33%)  4 7/30 (23.33%)  7
Nausea  1  1/30 (3.33%)  1 3/30 (10.00%)  3 1/30 (3.33%)  1 0/30 (0.00%)  0
Vomiting  1  1/30 (3.33%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1 2/30 (6.67%)  2
Constipation  1  0/30 (0.00%)  0 3/30 (10.00%)  3 1/30 (3.33%)  1 0/30 (0.00%)  0
Gastroenteritis  1  3/30 (10.00%)  3 2/30 (6.67%)  2 2/30 (6.67%)  2 1/30 (3.33%)  1
Taste perversions  1 [1]  3/30 (10.00%)  3 4/30 (13.33%)  4 2/30 (6.67%)  2 2/30 (6.67%)  2
Polydipsia  1  2/30 (6.67%)  2 2/30 (6.67%)  2 1/30 (3.33%)  1 1/30 (3.33%)  1
Esophageal ulcer  1  1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
General disorders         
Pain  1  4/30 (13.33%)  4 4/30 (13.33%)  4 5/30 (16.67%)  5 4/30 (13.33%)  4
Fatigue  1  5/30 (16.67%)  5 7/30 (23.33%)  7 3/30 (10.00%)  3 4/30 (13.33%)  4
Asthenia  1  1/30 (3.33%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0
Chest Pain  1  1/30 (3.33%)  1 2/30 (6.67%)  2 4/30 (13.33%)  4 3/30 (10.00%)  3
Fever  1  1/30 (3.33%)  1 1/30 (3.33%)  1 2/30 (6.67%)  2 1/30 (3.33%)  1
Decreased libido  1  1/30 (3.33%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1 2/30 (6.67%)  2
Immune system disorders         
Allergic Infection  1  2/30 (6.67%)  2 1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0
Infections and infestations         
Viral Infection  1  2/30 (6.67%)  2 3/30 (10.00%)  3 1/30 (3.33%)  1 2/30 (6.67%)  2
General Infection  1  1/30 (3.33%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1
Infection Fungal  1  1/30 (3.33%)  1 2/30 (6.67%)  2 1/30 (3.33%)  1 1/30 (3.33%)  1
Metabolism and nutrition disorders         
Edema  1  4/30 (13.33%)  4 4/30 (13.33%)  4 5/30 (16.67%)  5 3/30 (10.00%)  3
Dehydration  1  2/30 (6.67%)  2 1/30 (3.33%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders         
Arthritis  1  3/30 (10.00%)  3 2/30 (6.67%)  2 1/30 (3.33%)  1 1/30 (3.33%)  1
Leg Cramps  1  2/30 (6.67%)  2 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Nervous system disorders         
Headache  1  1/30 (3.33%)  1 2/30 (6.67%)  2 1/30 (3.33%)  1 1/30 (3.33%)  1
Back Pain  1  1/30 (3.33%)  1 3/30 (10.00%)  3 3/30 (10.00%)  3 3/30 (10.00%)  3
Dizziness  1  3/30 (10.00%)  3 3/30 (10.00%)  3 2/30 (6.67%)  2 4/30 (13.33%)  4
Vertigo  1  3/30 (10.00%)  3 2/30 (6.67%)  2 4/30 (13.33%)  4 3/30 (10.00%)  3
Somnolence  1  1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Depression  1  1/30 (3.33%)  1 4/30 (13.33%)  4 1/30 (3.33%)  1 1/30 (3.33%)  1
Psychiatric disorders         
Anorexia  1  0/30 (0.00%)  0 4/30 (13.33%)  4 0/30 (0.00%)  0 0/30 (0.00%)  0
Renal and urinary disorders         
Urinary Tract Infection  1  2/30 (6.67%)  2 3/30 (10.00%)  3 1/30 (3.33%)  1 1/30 (3.33%)  1
Polyuria  1  1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Rhinitis  1  3/30 (10.00%)  3 2/30 (6.67%)  2 3/30 (10.00%)  3 3/30 (10.00%)  3
Bronchitis  1  3/30 (10.00%)  3 1/30 (3.33%)  1 2/30 (6.67%)  2 3/30 (10.00%)  3
Increased Cough  1  1/30 (3.33%)  1 2/30 (6.67%)  2 1/30 (3.33%)  1 0/30 (0.00%)  0
Sinusitis  1  1/30 (3.33%)  1 2/30 (6.67%)  2 3/30 (10.00%)  3 2/30 (6.67%)  2
Skin and subcutaneous tissue disorders         
Rash  1  3/30 (10.00%)  3 1/30 (3.33%)  1 1/30 (3.33%)  1 2/30 (6.67%)  2
Pruritus  1  1/30 (3.33%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Skin Ulcer  1  0/30 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Predominantly metallic taste
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Alexander Kharlamov
Organization: Ural Institute of Cardiology, Ural State Medical Academy
Phone: +79638547663
EMail: drskharlamov@gmail.com
Layout table for additonal information
Responsible Party: Alexander Kharlamov, Ural Medical University
ClinicalTrials.gov Identifier: NCT01265615     History of Changes
Other Study ID Numbers: VDCRS03
First Submitted: December 22, 2010
First Posted: December 23, 2010
Results First Submitted: December 27, 2010
Results First Posted: June 21, 2011
Last Update Posted: June 9, 2015