Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Kidney Transplantation. (PARIDOINAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01939977|
Recruitment Status : Completed
First Posted : September 11, 2013
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Secondary Hyperparathyroidism Due to Renal Causes||Drug: Paricalcitol Drug: Calcifediol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Paricalcitol in the Reduction of Secondary Hyperparathyroidism After Renal Transplantation.|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
Paricalcitol oral capsules.
1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours.
Other Name: Zemplar
Active Comparator: Calcifediol
Calcifediol oral drops.
5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment.
Other Name: Hidroferol
- Percentage of Patients With iPTH Serum Concentration >110 pg/mL. [ Time Frame: 6 months ]Percentage of patients with iPTH serum concentration >110 pg/mL 6 month after transplant.
- Change on iPTH Serum Concentration. Intention to Treat Analysis. [ Time Frame: 6 months ]Change on iPTH serum concentration on each treatment group 6 month post transplantation.
- Percentage of Patients That Reach at Least a 30% iPTH Reduction at the End of the Study. [ Time Frame: 6 months ]
- Percentage of Patients With iPTH Levels Between 70-110 pg/mL at the End of the Study. ITT. [ Time Frame: 6 month ]
- Percentage of Patient With Presence of Calcifications on Protocol Renal Biopsies at 6 Months After Treatment in Each Treatment Group. [ Time Frame: 6 months ]
- Patients That Suffered the Following Events: Acute Rejection, Acute Rejection Confirmed With Biopsy and/or Subclinic Rejection and/or Chronic Damage. [ Time Frame: 6 months ]Patients with at least one of the following events: acute rejection, acute rejection confirmed with biopsy and/or subclinic rejection and/or chronic damage.
- Change on Concentration of Bone Markers (Osteocalcin) at 6 Months After Transplantation on Each Treatment Group. [ Time Frame: 6 months ]
- Percentage of Patients With Acute Rejection at 6 Months After Transplantation and Treatment on Each Treatment Group. [ Time Frame: 6 months ]
- Percentage of Patients With Microalbuminuria on Months 1, 3 and 6 Post Transplantation. [ Time Frame: Months 1, 3 and 6 ]
- Percentage of Patients on Each Stage of Renal Function on Months 1, 3 and 6 Post Transplantation. [ Time Frame: Months 1, 3 and 6 ]
- Evolution of Speed of Pulse Wave From Month 1 to Month 6 Post Transplantation. [ Time Frame: 6 months. ]Baseline speed of pulse wave was performed between 1 week and 1 month post transplant; next measure of speed of pulse wave performed at month 6 post transplant.
- Percentage of Patients With Hypercalcemia on Each Treatment Group at 6 Months Post Transplantation. [ Time Frame: 6 months ]Percentage of patients with hypercalcemia (defined as serum calcium levels > 10,3 mg/dl) on each treatment group at 6 months post transplantation.
- Evolution of Anti-HLA Antibodies (PRA) From Basal to Month 6 Post-transplantation. [ Time Frame: 6 months ]HLAs corresponding to MHC (major histocompatibility complex) class I (A, B, and C) present peptides from inside the cell. HLAs corresponding to MHC class II (DP, DM, DO, DQ, and DR) present antigens from outside of the cell to T-lymphocytes.
- Frequency of Adverse Events or Serious Adverse Events That Occurs During the Study on Each Treatment Group. [ Time Frame: 6 months ]
- Change on Concentration of Bone Markers (Alkaline Phosphatase) at 6 Months After Transplantation on Each Treatment Group. [ Time Frame: 6 months ]
- Change on Concentration of Bone Markers (FGF-23) at 6 Months After Transplantation on Each Treatment Group [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939977
|Hospital Universitari Germans Trias I Pujol de Badalona|
|Badalona, Barcelona, Spain, 08916|
|Hospital Universitari de Bellvitge|
|L'Hospitalet de Llobregat, Barcelona, Spain, 08907|
|Hospital Universitario Marqués de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Hospital Del Mar|
|Barcelona, Spain, 08003|
|Barcelona, Spain, 08025|
|Hospital Universitari Vall D'Hebron|
|Barcelona, Spain, 08035|
|Hospital Puerta Del Mar|
|Cádiz, Spain, 11009|
|Hospital Reina Sofía|
|Córdoba, Spain, 14004|
|Complexo Hospitalario Universitario A Coruna|
|La Coruna, Spain, 15006|
|Complejo Hospitalario Universitario de Canarias|
|Las Palmas De Gran Canaria, Spain, 38320|
|Hospital Ramón Y Cajal|
|Madrid, Spain, 28034|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Complejo Hospitalario Regional de Málaga|
|Málaga, Spain, 29010|
|Hospital Virgen Del Rocío|
|Sevilla, Spain, 41013|
|Hospital Universitari I Politècnic La Fe|
|Valencia, Spain, 46026|
|Hospital Universitario Miguel Servet|
|Zaragoza, Spain, 50009|
|Principal Investigator:||Josep M Cruzado, Dr||Fundación SENEFRO - Hospital Universitario de Bellvitge - Barcelona.|