Hyperparathyroidism, SecondaryPhase 22MD-7H-2BNCT01922843
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
A Phase 2 study testing DP001 softgel capsules in people with Hyperparathyroidism, Secondary and Kidney Failure, Chronic, run by Deltanoid Pharmaceuticals at 14 sites in United States.
Trial summary
The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic
- What is being tested?
- DP001 softgel capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 14 sitesUnited States
- Study dates
- Sep 2013to Jun 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and non-pregnant women ≥18 years of age
- Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months prior to Screening Phase
- Patient is currently being treated with pharmaceutical vitamin D for the treatment of secondary hyperparathyroidism
- Serum iPTH value ≤500 pg/mL at first screening visit
- Total serum calcium (corrected for albumin) ≤10.5 mg/dL at first screening visit
- Serum phosphorus ≤7.0 mg/dL at first screening visit
Who cannot join
- Currently taking any of the following: drugs affecting vitamin D metabolism, digitalis, glucocorticoids, cyclosporine or other immunosuppressants, aluminum-based phosphate binders
- A daily intake >4000 IU vitamin D (D3 + D2)
- Any investigational drug use within 10 half-lives of the drug (or within the previous 30 days if the half-life of the drug is unknown)
- History of any of the following: ventricular dysrhythmias, severe congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, coronary artery bypass grafting, multiple myeloma, calciphylaxis, active malignancy, end-stage liver disease, active infections, clinically significant renal/urinary tract stones, sarcoidosis, tuberculosis, parathyroidectomy
- Major surgery within the past 3 months
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Charlotte, North Carolina
Study site
Cincinnati, Ohio
Study site
Evanston, Illinois
Study site
Fort Worth, Texas
Study site
Grand Prairie, Texas
Study site
Great Neck, New York
Study site
Las Vegas, Nevada
Study site
Nashville, Tennessee
Study site
Phoenix, Arizona
Study site
Ridgewood, New York
Study site
San Antonio, Texas
Study site
St Louis, Missouri
Study site
Tucson, Arizona
Study site
Washington D.C., District of Columbia
About this study
Official title: A Phase 2B, Double-blind, Randomized, Placebo-controlled, Proof-of-concept Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study of the vitamin D analog 2-methylene-19-nor-20S-1α,25-dihydroxyvitamin D3 (DP001) in patients with end-stage renal disease (ESRD). The effect of 12 weeks of oral administration of DP001 on serum parathyroid hormone (PTH) levels will be evaluated in ESRD patients who have secondary hyperparathyroidism.
- Being tested
- DP001 softgel capsules, Placebo
- Keywords
- Hemodialysis
- Medical subject headings
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP001 softgel capsulesDrug
Also called 2-methylene-19-nor-20S-1α,25-(OH)2D3, PF-00217763, 2MD
PlaceboDrug
Also called Placebo soft gel capsules
| Study group | Role | What they receive |
|---|---|---|
| DP001 | Experimental | DP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks Receives: Drug: DP001 softgel capsules |
| Placebo | Placebo comparator | Placebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level
Measured: 12 weeks, with weekly iPTH measurements
Secondary outcomes (1)
Mean percentage change in serum iPTH
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperparathyroidism, SecondaryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deltanoid Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravi Thadhani, MD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922843
- Sponsor's protocol ID
- 2MD-7H-2B
- Acronym
- 2MD-7H-2B
- Status last verified
- Aug 2017
- First submitted
- 12 Aug 2013
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thadhani R, Zella JB, Knutson DC, Blaser WJ, Plum LA, Clagett-Dame M, Buck RD, DeLuca HF. 2MD (DP001), a Single Agent in the Management of Hemodialysis Patients: A Randomized Trial. Am J Nephrol. 2017;45(1):40-48. doi: 10.1159/000452680. Epub 2016 Nov 24.
PubMed 27880946
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2B, Double-blind, Randomized, Placebo-controlled, Proof-of-concept Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT01922843
- Acronym / sponsor ID
- 2MD-7H-2B / 2MD-7H-2B
- Keywords
- Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Deltanoid PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Aug 2013 (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.
The goal of this study is to test a new vitamin D compound for its ability to reduce parathyroid hormone levels in patients who are on hemodialysis.
Detailed description
This is a randomized, double-blind, placebo-controlled study of the vitamin D analog 2-methylene-19-nor-20S-1α,25-dihydroxyvitamin D3 (DP001) in patients with end-stage renal disease (ESRD). The effect of 12 weeks of oral administration of DP001 on serum parathyroid hormone (PTH) levels will be evaluated in ESRD patients who have secondary hyperparathyroidism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DP001 | Experimental | Drug: DP001 softgel capsulesDP001 softgel capsules, 440 ng taken orally three times weekly after dialysis for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo softgel capsules, taken orally three times weekly after dialysis for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and non-pregnant women ≥18 years of age
- Patient is diagnosed with ESRD and must be on hemodialysis 3 times per week for at least 3 months prior to Screening Phase
- Patient is currently being treated with pharmaceutical vitamin D for the treatment of secondary hyperparathyroidism
- Serum iPTH value ≤500 pg/mL at first screening visit
- Total serum calcium (corrected for albumin) ≤10.5 mg/dL at first screening visit
Key exclusion criteria (5 listed)
- Currently taking any of the following: drugs affecting vitamin D metabolism, digitalis, glucocorticoids, cyclosporine or other immunosuppressants, aluminum-based phosphate binders
- A daily intake >4000 IU vitamin D (D3 + D2)
- Any investigational drug use within 10 half-lives of the drug (or within the previous 30 days if the half-life of the drug is unknown)
- History of any of the following: ventricular dysrhythmias, severe congestive heart failure, angina pectoris, myocardial infarction, coronary angioplasty, coronary artery bypass grafting, multiple myeloma, calciphylaxis, active malignancy, end-stage liver disease, active infections, clinically significant renal/urinary tract stones, sarcoidosis, tuberculosis, parathyroidectomy
- Major surgery within the past 3 months
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 |
|---|---|---|
| DP001 softgel capsulesAlso: 2-methylene-19-nor-20S-1α,25-(OH)2D3, PF-00217763, 2MD | Drug | DP001 |
| PlaceboAlso: Placebo soft gel capsules | Drug | Placebo |
Primary outcome
The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level
Time frame: 12 weeks, with weekly iPTH measurements
1 secondary outcome
Mean percentage change in serum iPTH
Time frame: Baseline to 12 weeks
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 18 Aug 2017.
- Derived from this study: PubMed 27880946Thadhani R, Zella JB, Knutson DC, Blaser WJ, Plum LA, Clagett-Dame M, Buck RD, DeLuca HF. 2MD (DP001), a Single Agent in the Management of Hemodialysis Patients: A Randomized Trial. Am J Nephrol. 2017;45(1):40-48. doi: 10.1159/000452680. Epub 2016 Nov 24.
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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.
Ravi Thadhani, MD study chair
Massachusetts General Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DP001 softgel capsules in people with Hyperparathyroidism, Secondary and Kidney Failure, Chronic, run by Deltanoid Pharmaceuticals at 14 sites 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 5 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 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The proportion of patients who achieve two consecutive > or = 30% decreases from his/her baseline serum iPTH level (time frame: 12 weeks, with weekly iPTH measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922843, which also lists 1 linked publication.
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 18 Aug 2017.