Denosumab for Prevention of Osteoporosis in Renal Transplant Recipients

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to examine the effect of denosumab on lumbar spine bone mineral density (BMD) after one year of treatment in newly transplanted renal allograft recipients. Secondary endpoints include BMD changes at the total hip and the femoral neck, changes in body height, changes in bone mineral metabolism parameters, incidence of fractures, and allograft function at one year. Safety measurements include the occurrence of rejection episodes, infectious complications, graft loss and mortality.

• Trial with medicinal product

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rudolf Wuethrich
• Treatments: Denosumab

Criteria

The key inclusion criteria are:

1. Male or female adult de novo kidney, kidney-pancreas or kidney-islet, or kidney-liver transplant recipients

2. Functioning graft within 28 days after transplantation (creatinine having decreased to <200 micromol/l without the need for dialysis)

3. Being on standard triple immunosuppression including a calcineurin antagonist (cyclosporine or tacrolimus), mycophenolate (MMF or MPA) and steroids, with or without induction treatment with basiliximab or anti-thymocyte globulin

Key exclusion criteria are:

1. Age <18 years

2. Rising creatinine after initial drop <200 micromol/l or creatinine >200 micromol/l at baseline

3. Evidence of early acute rejection, either suspected clinically and/or proven by biopsy

4. Presence of severe osteoporosis as evidenced by a T score <-4 at the hip, femoral neck or any of the 4 vertebrae L1 to L4

5. Evidence of severe hyper- or hypoparathyroidism (iPTH >800 ng/l or <10 ng/l)

6. Hypocalcemia (total calcium <1.8 mmol/l) or hypercalcemia (total calcium >2.7 mmol/l)

7. Steroid-free de novo immunosuppression scheme