Proteinuria
Conditions
Keywords
kidney transplant patients, Albuminuria
Brief summary
The main objective of this study is to examine if paricalcitol may reduce progression of graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials with paricalcitol are performed in renal transplant patients examining the effect on proteinuria and graft fibrosis.
Detailed description
77 randomized, 37 paricalcitol, 40 no treatment
Interventions
DRUGParicalcitol
Zemplar (paricalcitol) 2ug daily, oral intake
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* kidney transplant patients
Exclusion criteria
* Previously transplanted
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in albumin/creatinine ratio from baseline to end of study. | 1 year | Albumin will be measured in spot urine as albumin/creatinine ratio in mg/mmol. Assuming a type 1 error of 5% and at type II error of 20 %, with a clinically relevant difference in 3.5 mg/mmol from a baseline value of 15.0 + 10 mg/mmol the estimated number of patients in each arm should be 65, assuming a correlation between start and end value of 0.5. |
Countries
Norway
Outcome results
None listed