Oral Paricalcitol in Kidney Transplant Recipients

NCT00587158 | Completed Results DMC

• 1 other identifier: 256-06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This study is being done to find out whether patients who receive a kidney transplant can benefit from taking the medication paricalcitol (trade name Zemplar®) as compared to kidney transplant recipients not taking this medication. The main possible benefits being studied are:

• Lower risk for overactive parathyroid glands after kidney transplantation.
• Lower risk of low bone density in the spine and hip after kidney transplantation. By dividing patients in the study into a group receiving Zemplar® and a group not receiving Zemplar®, it will be possible to understand the good and bad effects of Zemplar® during the first year after a kidney transplant.

Conditions

Transplant; Failure, Kidney; Renal Disease, End Stage; Hyperparathyroidism, Secondary

Keywords

Paricalcitol; Parathyroid Hormone; Bone Alkaline Phosphatase; Chronic Kidney Disease; Glomerular Filtration Rate; Vitamin D Receptor; Interstitial Fibrosis and Tubular Atrophy; Zemplar®

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Hyperparathyroidism at One Year

  Parathyroid hormone (PTH) is a measure of how well the parathyroid gland is working and is measured by a blood test. Hyperparathyroidism (increased PTH) is defined as PTH blood value greater than 65 picograms/milliliter in the absence of hypocalcemia (low calcium) or if the subject had a parathyroidectomy (surgical removal of parathyroid glands) during the first year post-transplant.

  1 year post kidney transplant

Secondary Outcomes (12)

• Number of Subjects With Osteopenia/Osteoporosis of the Hip at One Year

  1 year post kidney transplant

• Number of Subjects With Osteopenia/Osteoporosis of the Lumbar Spine at One Year

  1 year post kidney transplant

• Serum Parathyroid Hormone (PTH) Level Over Time

  Baseline, 3 weeks, 3 months, 1 year post kidney transplant

• Serum Bone Alkaline Phosphatase (BAP) Level Over Time

  Baseline, 21 days, 90 days and 1 year post kidney transplant

• Change in Lumbar Spine Bone Mineral Density (BMD)

  Baseline, 1 year post kidney transplant

Study Arms (2)

Immunosuppression without paricalcitol (control)

OTHER

Subjects will receive the standard immunosuppressive therapies consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).

Other: Corticosteroid Avoidance Immune Suppression Protocol

Immunosuppression with paricalcitol

ACTIVE COMPARATOR

Subjects will receive the standard immunosuppressive therapy consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®). In addition, subjects will receive the study medication paricalcitol (Zemplar®).

Drug: Paricalcitol; Other: Corticosteroid Avoidance Immune Suppression Protocol

Interventions

Paricalcitol DRUG

Zemplar® - this medicine, which is the medicine being studied, will be given as a capsule containing 1 microgram of Zemplar® once daily beginning the day after the transplant. It will be continued at the same dose for the first two weeks then, depending on the results of blood and urine testing, will be increased to 2 micrograms daily. The dose will remain at 2 micrograms daily until the end of the study unless there is a medical reason to reduce or stop it or unless the study is stopped early.

Also known as: Brand name is Zemplar®

Immunosuppression with paricalcitol

Corticosteroid Avoidance Immune Suppression Protocol OTHER

Induction with Alemtuzumab and maintenance with Tacrolimus and Mycophenolate Mofetil. With standard antimicrobial prophylaxis and calcium supplementation.

Also known as: Standard Immune Suppression

Immunosuppression with paricalcitol; Immunosuppression without paricalcitol (control)

Eligibility Criteria

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

You may qualify if:

• Age 18 years and older.
• First or second deceased donor or living donor renal transplant.
• Normocalcemia or hypocalcemia.
• Willing to give informed consent

You may not qualify if:

• Third or subsequent renal transplant.
• Incompatible blood type or positive cross-match donor.
• Multiple organ transplant recipients.
• Diabetic with plans for future pancreas or islet transplant.
• Evidence of donor-specific sensitization (positive T-cell and/or B-cell flow cytometric cross-match).
• Documented hypercalcemia (total serum calcium 10.5 mg/dl on two separate occasions) prior to transplantation.
• Serum 25(OH)vitamin D concentration ≤ 10 ng/ml

Sponsors & Collaborators

• Mayo Clinic: lead
• Abbott: collaborator

Study Sites (2)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Renal Insufficiency, Chronic; Pulmonary Fibrosis

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis

Results Point of Contact

• Title: Hatem Amer, MD, FASN; Assistant Professor of Medicine; Division of Nephrology and Hypertension
• Organization: Mayo Clinic

amer.hatem@mayo.edu

507-256-1963

Study Officials

• Hatem Amer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: January 1, 2007
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: May 13, 2013
• Results First Posted: May 8, 2013

Record last verified: 2013-05

Locations

US (2)