Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria

NCT01694160 | Completed Phase 3 DMC

• 2 other identifiers: 2012/107 D2012-000429-32
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Proteinuria

Keywords

kidney transplant patients; Albuminuria

Outcome Measures

Primary Outcomes (1)

• Change in albumin/creatinine ratio from baseline to end of study.

  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.

  1 year

Study Arms (2)

Paricalcitol

EXPERIMENTAL

Paricalcitol 2 ug/daily for 48 weeks

Drug: Paricalcitol

no intervention

NO INTERVENTION

Interventions

Paricalcitol DRUG

Zemplar (paricalcitol) 2ug daily, oral intake

Paricalcitol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• kidney transplant patients

You may not qualify if:

• Previously transplanted

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Renal Section, Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

Related Publications (2)

• 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.

  PMID: 33326471 DERIVED

• 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.

  PMID: 30134956 DERIVED

MeSH Terms

Conditions

Proteinuria; Albuminuria

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hallvard Holdaas, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrology

Study Record Dates

• First Submitted: September 23, 2012
• First Posted: September 27, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)