Mineral Metabolism and Vascular Effects of Vitamin D Therapy in Kidney Transplant Patients

NCT00646282 | Terminated Phase 4 Results

• 1 other identifier: IRB00006614
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with kidney failure on dialysis can be successfully transplanted. However, many of them do not attain a normal kidney function and/or present a slow deterioration of kidney function after transplantation. As a consequence, they can develop an endocrine disorder called hyperparathyroidism, which can cause bone disease and a high risk of bone fractures. In spite of the known bone disease and hyperparathyroidism, there is no well defined treatment for these patients. Moreover, kidney transplant recipients present a higher mortality rate compared to the general population, and the principal cause of death is cardiovascular disease. Dialysis patients are known to have extensive cardiovascular calcifications and increased vascular stiffness, and these factors have been closely associated with cardiovascular mortality. The effect of vitamin D on bone health is well known in the general population. Many studies showed a reduction in fracture rate in post-menopausal women and older men receiving vitamin D and calcium supplements. Vitamin D analogues are also commonly used to treat hyperparathyroidism in dialysis patients. Finally, vitamin D has been suggested to have beneficial effects on the cardiovascular system and to reduce mortality in dialysis patients. Hectorol® is a vitamin D analog which has been demonstrated to effectively treat hyperparathyroidism in dialysis and pre-dialysis patients. The effects of vitamin D supplementation on bone disease, hyperparathyroidism and cardiovascular function in kidney transplant recipients have not been properly studied. Whether Hectorol® therapy helps reducing the severity of bone disease and improving vascular function in kidney transplant recipients is still unknown.

Conditions

Hyperparathyroidism, Secondary

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With 50% Reduction of Intact Parathyroid Hormone (iPTH) Levels

  Number of participants that have 50% reduction in iPTH levels (but not lower than 65 pg/ml) at 18 months

  18 months

Study Arms (2)

Doxercalciferol

EXPERIMENTAL

Stable kidney transplant recipients will receive Doxercalciferol

Drug: doxercalciferol

Control

NO INTERVENTION

Stable kidney transplant recipients will not receive any drug

Interventions

doxercalciferol DRUG

The study drug dosage will be initiated according to baseline iPTH levels. For patients with iPTH\>300 pg/ml, oral Doxercalciferol will be given at 1 mcg/day; for patients with iPTH \<300 pg/ml, oral Doxercalciferol will be initiated at 0.5 mcg/day.

Also known as: Hectorol

Doxercalciferol

Eligibility Criteria

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

You may qualify if:

• Kidney transplant recipient \> 18 year/old with reduced and stable kidney function (estimated GFR 25-60 ml/min/1.73m2)
• iPTH levels between 120 and 500 pg/ml
• Stable immunosuppressive therapy (5-10 mg Prednisone/day, stable dosage of calcineurin inhibitors, or other immunosuppressive agents for at least 6 months)

You may not qualify if:

• Recent rejection episode (\< 3 months)
• One of the following: baseline estimated GFR\>60 ml/min/1.73m2 or \<25 ml/min/1.73m2, albumin-corrected Ca\>9.5 mg/dl or serum phosphorus \>4.6 mg/dl.
• Recipients of dual transplant organs with exception of kidney-pancreas
• Patients already receiving treatment with Vitamin D analogues
• Severe peripheral vascular disease or coronary artery disease
• History of previous parathyroidectomy
• Current alcohol or drug abuse
• Pregnant or nursing woman or female of child-bearing age not receiving contraception
• Other comorbidities that in the opinion of the investigators would reduce expected patient's survival and preclude study completion
• Medications that could interfere with Hectorol® metabolism

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Limitations and Caveats

Due to slow enrollment and primary investigator leaving institution, the study was terminated. Subjects were notified and those on active drug returned to their physicians to be treated according to standard of care.

Results Point of Contact

• Title: Dr. Antonio Guasch
• Organization: Emory University

aguasch@emory.edu

404-727-2522

Study Officials

• Paolo Raggi and Antonio Guasch, MDs

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2008
• First Posted: March 28, 2008
• Study Start: April 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 26, 2015
• Results First Posted: January 26, 2015

Record last verified: 2015-01

Locations

US (1)