Cardiorenal Syndrome Clinical Trial
Official title:
Phase 4 Study of Paricalcitol and Calcitriol for Reparative Management of Chronic Allograft Dysfunction and Renocardiac Syndrome in Vitamin D Insufficient Renal Transplant Recipients
Verified date | May 2015 |
Source | Ural Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Russia: Ethics Committee |
Study type | Interventional |
We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for the management of chronic allograft dysfunction (CAD), protection and repair of kidney and heart, management of chronic renocardiac syndrome (CRS). We assume that paricalcitol can have some advantages if compare with calcitriol or cholecalciferol due to absence of calcemic and phosphatemic complications alongside with great beneficial potential.
Status | Completed |
Enrollment | 109 |
Est. completion date | September 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age 40-75 - Male - History of chronic kidney disease and cardiorenal syndrome - Written informed consent Exclusion Criteria: - Female - Acute illness - Life-threat competitive illness - Mental disorders - Endocrinologic diseases (including diabetes mellitus, hyperparathyroidism, and other thyroid disorders) - Need for dialyses - Hypercalcemia - Concomitant use of hormone or cytokine medication - Participation to any drug-investigation during the previous 60 days as checked with VIP check |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | De Haar Research Foundation | Rotterdam | South Holland |
Russian Federation | Ural Institute of Cardiology | Yekaterinburg |
Lead Sponsor | Collaborator |
---|---|
Ural Medical University | De Haar Research Foundation, Ural Institute of Cardiology |
Netherlands, Russian Federation,
Kharlamov AN, Perrish AN, Gabiskii IaL, Ronne Kh, Ivanova EIu. [Vitamin D in the treatment of cardiorenal syndrome in patients with chronic nephropathy]. Kardiologiia. 2012;52(3):33-44. Russian. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CAD (Chronic Allograft Dysfunction) Degree | 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) |
day 180 after Tx (transplantation) | Yes |
Secondary | Heart Failure (HF) | 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. |
on day 180 after Tx (transplantation) | Yes |
Secondary | GFR (Glomerular Filtration Rate) | 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. | on day 180 | No |
Secondary | CAD (Chronic Allograft Dysfunction) Degree | 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) |
on day 90 | Yes |
Secondary | Serum Creatinine | 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) | on day 180 after Tx | No |
Secondary | Number of Circulating SP (Side Population) Stem-Progenitor Cells | 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). | on day 180 | No |
Secondary | VDR (Vitamin D Receptor) Expression in Myocardium | 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. | on day 180 | No |
Secondary | VDR (Vitamin D Receptor) Expression in Kidney | 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. | on day 180 | No |
Secondary | Systolic Blood Pressure | SBP measured by routine method | on day 180 | No |
Secondary | Coronary Calcium Score | 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. | on day 180 | No |
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