Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

NCT ID: NCT01694160

Last Updated: 2016-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-12-31

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

Conditions

Proteinuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paricalcitol

Paricalcitol 2 ug/daily for 48 weeks

Group Type: EXPERIMENTAL

Paricalcitol

Intervention Type: DRUG

Zemplar (paricalcitol) 2ug daily, oral intake

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Paricalcitol

Zemplar (paricalcitol) 2ug daily, oral intake

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• kidney transplant patients

Exclusion Criteria

• Previously transplanted

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hallvard Holdaas

Consultant Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hallvard Holdaas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Renal Section, Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Countries

Norway

References

Pihlstrom HK, Ueland T, Michelsen AE, Aukrust P, Gatti F, Hammarstrom C, Kasprzycka M, Wang J, Haraldsen G, Mjoen G, Dahle DO, Midtvedt K, Eide IA, Hartmann A, Holdaas H. Exploring the potential effect of paricalcitol on markers of inflammation in de novo renal transplant recipients. PLoS One. 2020 Dec 16;15(12):e0243759. doi: 10.1371/journal.pone.0243759. eCollection 2020.

Reference Type: DERIVED

PMID: 33326471 (View on PubMed)

Ussif A, Pihlstrom H, Pasch A, Holdaas H, Hartmann A, Smerud K, Asberg A. Paricalcitol supplementation during the first year after kidney transplantation does not affect calcification propensity score. BMC Nephrol. 2018 Aug 22;19(1):212. doi: 10.1186/s12882-018-1000-8.

Reference Type: DERIVED

PMID: 30134956 (View on PubMed)

Other Identifiers

2012-000429-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2012/107 D

Identifier Type: -

Identifier Source: org_study_id