Chronic Kidney DiseasePhase 4NCT00889629
Pilot Study Evaluating Doxercalciferol Replacement Therapy in Kidney Transplant Recipients
A Phase 4 study testing Doxercalciferol and 25-OH Vitamin D3 in people with Chronic Kidney Disease and Kidney Transplantation, run by Mariana Markell at 1 site in United States.
Trial summary
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Kidney Disease, Kidney Transplantation
- What is being tested?
- Doxercalciferol and 25-OH Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults of both genders between the ages of 18 and 65.
- Kidney transplant at least 1 year prior to enrollment
- Creatinine value of <2.5 mg/dl with no excursion >0.5 within the past 3 months
- Proteinuria of 500 mg/24 hours or a protein/creatinine ratio of 0.5 or greater
- Hypovitaminosis D, as defined by a 25-OH Vitamin D value of <25 ng/ml
- Intact PTH value between 150 and 600 pg/ml
Who cannot join
- History of parathyroidectomy
- History of prior intolerance to vitamin D therapy (not including hypercalcemia)
- History of biopsy proven acute rejection over the 3 months preceding enrollment
- Recent (over the past month) addition of an ACE inhibitor or Angiotensin -
- Receptor Blocking agent - patients who have been on a stable dose are acceptable
- Current use of active Vitamin D supplement (patients in whom therapy has been discontinued more than 1 month prior to enrollment are acceptable)
- Postmenopausal woman or women receiving hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Medical Center
Brooklyn, New York, 11234
About this study
Official title: Pilot Study: Effects of Hectorol (Doxercalciferol) Vitamin D Replacement on Proteinuria, PTH Level and Bone Turnover in Stable Kidney Transplant Recipients: a Single-Blind, Placebo-Controlled Study in Patients Receiving 25-OH Vitamin D3
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels. The investigators are examining the effects of doxercalciferol on parathyroid hormone levels, proteinuria and bone turnover markers in people who have had a kidney transplant.
Read the detailed description
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels.
25-OH Vitamin D3 is now recommended to treat kidney transplant patients with low vitamin D levels but it may not be enough to treat the parathyroid problems and bone disease. Doxercalciferol is a form of Vitamin D that has been used to treat bone disease and parathyroid problems in dialysis patients but has not yet been studied in patients with kidney transplants. We are interested in seeing whether doxercalciferol given together with 25-OH Vitamin D3 will be a better treatment for the overactive parathyroid gland and bone disease than 25-OH Vitamin D3 alone in patients with kidney transplants.
- Conditions
- Chronic Kidney Disease, Kidney Transplantation
- Being tested
- Doxercalciferol, placebo, 25-OH Vitamin D3
- Keywords
- kidney transplantation, kidney transplant recipients
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxercalciferolDrug
Also called Hectorol (the other name for Doxercalciferol)
Active group receives doxercalciferol (Hectorol) 1mcg
placeboDrug
Also called Placebo for doxercalciferol
Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol)
25-OH Vitamin D3Drug
Also called (cholecalciferol)
All groups received cholecalciferol
| Study group | Role | What they receive |
|---|---|---|
| Doxercalciferol | Experimental | Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Active group receives doxercalciferol (Hectorol) 1mcgwith active titration based on intact PTH plus 25-OH Vitamin D3 (cholecalciferol) 400 IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol if target PTH value is not achieved by the predetermined midpoint. Receives: Drug: Doxercalciferol; Drug: 25-OH Vitamin D3 |
| Cholecalciferol | Placebo comparator | Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol) plus 25-OH Vitamin D3 (cholecalciferol) 400IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol placebo if target PTH value is not achieved by the predetermined midpoint. Receives: Drug: placebo; Drug: 25-OH Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
- iPTH value of 100 pg/ml or lower
The number of patients achieving the target iPTH value of 100 pg/ml or lower measured. Change in the level of iPTH (baseline as compared with 3 and 6 months) using both absolute value and percent change from baseline.
Measured: 6 months
Secondary outcomes (4)
Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels
The Change in the levels of 1,25 D2 and D3, 25-OH Vitamin D3 levels (baseline as compared with 3 month and end of study)
Measured: 6 months
Change in FGF-23 levels
The Change in FGF-23 levels (baseline as compared with 3 and 6 months) were measured.
Measured: 6 months
Change in serum bone turnover markers
The Change in the levels of serum osteocalcin, bone alkaline phosphatase and n-telopeptide of Type I collagen levels (baseline versus 3 and 6 months
Measured: 6 months
Change in Protein/creatinine ratio
Change in the level of Protein/creatinine ratio and or 24 hour urine for protein (baseline as compared with 3 and 6 months)
- Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months)
The Change in the level of Protein/creatinine ratio (baseline as compared with 3 and 6 months)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startNov 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mariana Markell
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Responsible party
- Sponsor-investigator, Mariana Markell, State University of New York - Downstate Medical Center
- Investigators
- Mariana Markell, MD, Principal investigator, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889629
- Sponsor's protocol ID
- 08-080
- Status last verified
- Jan 2019
- First submitted
- 23 Apr 2009
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Effects of Hectorol (Doxercalciferol) Vitamin D Replacement on Proteinuria, PTH Level and Bone Turnover in Stable Kidney Transplant Recipients: a Single-Blind, Placebo-Controlled Study in Patients Receiving 25-OH Vitamin D3
- ClinicalTrials.gov ID
- NCT00889629
- Acronym / sponsor ID
- 08-080
- Conditions
- Chronic Kidney Disease, Kidney Transplantation
- Keywords
- kidney transplantation, kidney transplant recipients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Mariana MarkellUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Nov 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 29 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels. The investigators are examining the effects of doxercalciferol on parathyroid hormone levels, proteinuria and bone turnover markers in people who have had a kidney transplant.
Detailed description
People with kidney transplants often develop bone disease. One reason for bone disease may be overactivity of a gland in the neck called the parathyroid gland. Overactivity of the parathyroid gland may be caused by lack of Vitamin D in the body. It has recently been discovered that many patients with kidney transplants have low Vitamin D levels.
25-OH Vitamin D3 is now recommended to treat kidney transplant patients with low vitamin D levels but it may not be enough to treat the parathyroid problems and bone disease. Doxercalciferol is a form of Vitamin D that has been used to treat bone disease and parathyroid problems in dialysis patients but has not yet been studied in patients with kidney transplants. We are interested in seeing whether doxercalciferol given together with 25-OH Vitamin D3 will be a better treatment for the overactive parathyroid gland and bone disease than 25-OH Vitamin D3 alone in patients with kidney transplants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxercalciferol | Experimental | Drug: Doxercalciferol, Drug: 25-OH Vitamin D3Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Active group receives doxercalciferol (Hectorol) 1mcgwith active titration based on intact PTH plus 25-OH Vitamin D3 (cholecalciferol) 400 IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol if target PTH value is not achieved by the predetermined midpoint. |
| Cholecalciferol | Placebo comparator | Drug: placebo, Drug: 25-OH Vitamin D3Patients are randomized using an A B C D randomization scheme in which the patient and the primary investigator are blinded but the study staff is not. Group 2 receives placebo (dummy bottle with pills resembling doxercalciferol) plus 25-OH Vitamin D3 (cholecalciferol) 400IU. Safety labs and end point labs are monitored as per protocol, with the opportunity to increase the dose of doxercalciferol placebo if target PTH value is not achieved by the predetermined midpoint. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults of both genders between the ages of 18 and 65.
- Kidney transplant at least 1 year prior to enrollment
- Creatinine value of <2.5 mg/dl with no excursion >0.5 within the past 3 months
- Proteinuria of 500 mg/24 hours or a protein/creatinine ratio of 0.5 or greater
- Hypovitaminosis D, as defined by a 25-OH Vitamin D value of <25 ng/ml
Key exclusion criteria (7 listed)
- History of parathyroidectomy
- History of prior intolerance to vitamin D therapy (not including hypercalcemia)
- History of biopsy proven acute rejection over the 3 months preceding enrollment
- Recent (over the past month) addition of an ACE inhibitor or Angiotensin -
- Receptor Blocking agent - patients who have been on a stable dose are acceptable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxercalciferolAlso: Hectorol (the other name for Doxercalciferol)Active group receives doxercalciferol (Hectorol) 1mcg | Drug | Doxercalciferol |
| placeboAlso: Placebo for doxercalciferolGroup 2 receives placebo (dummy bottle with pills resembling doxercalciferol) | Drug | Cholecalciferol |
| 25-OH Vitamin D3Also: (cholecalciferol)All groups received cholecalciferol | Drug | Cholecalciferol, Doxercalciferol |
Primary outcome
- iPTH value of 100 pg/ml or lower
Time frame: 6 months
The number of patients achieving the target iPTH value of 100 pg/ml or lower measured. Change in the level of iPTH (baseline as compared with 3 and 6 months) using both absolute value and percent change from baseline.
4 secondary outcomes
Change in 1,25 D2 and D3, 25-OH Vitamin D3 levels
Time frame: 6 months
Change in FGF-23 levels
Time frame: 6 months
Change in serum bone turnover markers
Time frame: 6 months
Change in Protein/creatinine ratio
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Markell, MD principal investigator
State University of New York - Downstate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxercalciferol and 25-OH Vitamin D3 in people with Chronic Kidney Disease and Kidney Transplantation, run by Mariana Markell at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- iPTH value of 100 pg/ml or lower (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.