Clinical Trials Logo

Clinical Trial Summary

There is a well-documented increased risk for disordered mineral bone homeostasis in Kidney Transplant Recipients (KTRs) when compared to the general population, leading to a markedly increased risk for fragility fractures and their associated morbidity and mortality. A more uniform and rigorous evaluation of bone and mineral homeostasis,than is afforded to patients under "normal care", will result in better clinical outcomes in KTRs.


Clinical Trial Description

The aim is to comprehensively characterize the mineral metabolism and skeletal phenotype in kidney transplant recipients (KTRs) to being to identify risk factors for post-kidney transplant mineral bone disease (PKT-MBD); and to evaluate whether treatment of abnormalities in these parameters will improve skeletal health as quantified by bone mineral density (BMD), bone turnover markers (rate of skeletal remodeling) and Osteoprobe (a direct index of bone quality using reference point indentation technology. Participants in the rigorous evaluation arm will be followed with a) Mineral metabolism: blood calcium, phosphorus, parathyroid hormone (PTH), 25(OH) vitamin D; b) Bone turnover markers: bone-specific alkaline phosphatase, cross-linked C-telopeptide of type I collagen (CTx), and N-terminal propeptide of type I collagen (PINP); c)Bone Mineral Density using a Dual energy x-ray absorptiometry which is the standard method by which bone mass is measured clinically. NOTE: The use of the Osteoprobe was discontinued on 9/5/19 due to safety concerns from the FDA about the device in other trials/other sites. The Control Cohort is essentially an historical control group who will have received standard of care for the 18 months ending just prior to the enrollment of our Intervention Cohort. A coincident Control Cohort will not be used because knowledge of the additional data to be collected in the Control Cohort will undoubtedly influence their care by their attending nephrologists and surgeons. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03958409
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date December 12, 2018
Completion date December 2, 2021

See also
  Status Clinical Trial Phase
Completed NCT04369456 - Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients N/A
Recruiting NCT06001320 - De-novo Initiation of Letermovir vs Valganciclovir for Cytomegalovirus Prophylaxis in AA Kidney Trans Recip Early Phase 1
Withdrawn NCT04560582 - Immunosuppression Reduction in Failed Allograft Guided by cfDNA
Not yet recruiting NCT05782543 - Renal Ex Vivo Warm Advanced Resuscitation Through Machine Perfusion N/A
Completed NCT03996551 - ExeRTiOn2- The Weight Gain Prevention Exercise in Renal Transplant Online Study N/A
Recruiting NCT05081141 - HHV8 and Solid Organ Transplantation
Recruiting NCT04508907 - A Study to Evaluate Preemptive Therapy in Hepatitis C (HCV) Organ Transplant Recipients Phase 4
Recruiting NCT06440330 - Define Predictors for Posttransplant Diabetes Mellitus Study
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Recruiting NCT04713774 - Bone Density and Vascular Calcifications Evolution After Renal Transplant
Active, not recruiting NCT05483725 - Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.
Recruiting NCT06095492 - Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus N/A
Active, not recruiting NCT04207177 - Immunosuppressive Drugs and Gut Microbiome: Pharmacokinetic- and Microbiome Diversity Effects Phase 4
Recruiting NCT03410654 - Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR. Early Phase 1
Completed NCT03373266 - Serun Fluoride and Kidney Transplant Phase 2
Completed NCT04835948 - Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
Not yet recruiting NCT04514666 - VOCs in Kidney and Liver Transplants N/A
Recruiting NCT03373500 - Effect of Dietary Salt Reduction on Blood Pressure in Kidney Transplant Recipients N/A
Recruiting NCT05900401 - Delayed Tolerance Through Mixed Chimerism Phase 1/Phase 2
Not yet recruiting NCT05166460 - Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation N/A