NephrolithiasisPhase 2NCT00860093
Efficacy and Safety of Using MPC-5971 in Subjects Undergoing Shock Wave Lithotripsy
A Phase 2 study testing MPC-5971 in people with Nephrolithiasis, run by Mission Pharmacal at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of MP-5971 in facilitating stone passage after Shock Wave Lithotripsy treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- MPC-5971
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2010to Dec 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject aged > or equal to 18 to < or equal to 70.
- Subject has undergone a computerized tomography (CT) scan within 30 days of the screening visit.
- Subject has been diagnosed with single unilateral renal calculus (target treatment stone).
- Target treatment stone, is presumed to be of calcium composition and/or uric acid composition.
- Target treatment stone is between > or equal to 5 and < or equal to 15 mm in diameter.
- Contra lateral kidney may hold a clinically inconsequential size calculus that does not require concurrent SWL treatment.
Show all 12Show fewer
- Both kidneys are anatomically normal.
- An appropriate candidate for SWL, determined by treating physician.
- Female subjects with a negative pregnancy test, hysterectomy, tubal ligation or non-child bearing potential (post-menopausal).
- Female subjects of child bearing potential with a negative pregnancy test and taking appropriate birth control for the duration of the study.
- Urine is pyuria negative and nitrite negative on dipstick and/or negative upon microscopic evaluation.
- Subject must voluntarily consent to participate in this study and provide his/her written informed consent prior to start of any study-specific procedures.
Who cannot join
- Current or past history of cystine stones or infection stones.
- Renal insufficiency, defined as serum creatinine value outside of the normal reference range.
- Currently has or had hyperkalemia within the past six months, defined as serum potassium outside of the normal reference range.
- Currently has or had hypermagnesemia within the past six months, defined as serum magnesium outside of the normal reference range.
- Active urinary tract infection.
- Renal calculi in an anatomically abnormal kidney; horseshoe shape, ureteropelvic junction obstruction or calyceal diverticulum.
Show all 26Show fewer
- Altered urinary tract anatomy such as a transplant kidney, urinary reconstruction or congenital anomaly.
- Blood coagulopathies and or taking anticoagulants (warfarin, coumarin, heparin).
- Taking salicylate (aspirin), including low dose aspirin for cardio-prophylaxis or other NSAID (OTC) that may increase bleeding time, within the past 7 days.
- History of complications with previous SWL; pyelonephritis, perinephric hematoma.
- Unsuccessful SWL treatments for previous stone within the past six months.
- Currently has or previously had ulcers of the esophagus, stomach and/or small intestines.
- Chronic diarrhea or has a history of diarrhea.
- Bowel disease such as Crohn's disease, Celiac disease, fat malabsorption or Sprue.
- Undergone any bariatric surgery procedures.
- Obese, defined as BMI >30.
- Uncontrolled hypertension defined as subjects taking medication specific for hypertension or subject not on medication with systolic blood pressure above 140 and diastolic above 90.
- Adrenal insufficiency (i.e., Addison's disease), adrenal tumors, and/or subjects on adrenal hormone replacement therapy.
- Taking potassium-sparing diuretics (triamterene, amiloride, spironolactone, Midamor®, Aldactone®, Dyrenium®, Eplerenone®).
- Taking potassium supplements (Rx or OTC) within the past 15 days.
- Taking magnesium supplements (Rx or OTC) within the past 15 days.
- Taken potassium citrate supplements (Rx or OTC) within the past 30 days.
- Subject taking anticholinergic medications at entry (dicyclomine, atropine, scopolamine, oxybutynin, tolerodine, Cogentin®, Sinemet®, Robinal®, Kenadrin®, Artane®, Enablex®, Detrol®, Vesicare®, Sanctura®, Ditropan®, Oxytrol®, Bentyl®, Byclomine®, Dibent®, Di-Spaz®, or Dilomine®). (Subjects may be prescribed anticholinergics as standard of care with use of stents post entry.)
- Subject is has taken gastrointestinal enzyme replacement therapy or proton pump inhibitors within past 30 days (Ultrase®, Creon®, Viokase®, Pancrease® MT, pancrelipase agents, Aciphex®, Nexium®, Prevacid®, Protonix®, Zegerid® Prilosec OTC®, Kapidex®, rabeprazole, esomeprazole, lansoprazole, pantoprazole, omeprazole, dexlansoprazole).
- Women who are pregnant or lactating.
- Subjects with a known hypersensitivity to potassium, magnesium, citrate or any excipients in the drug formulation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Columbus Urology Research
Columbus, Ohio, 43220
Urology Clinics of North Texas, PA
Dallas, Texas, 75231
Idaho Urologic Institute
Meridian, Idaho, 83642
About this study
Official title: A Multi-Site Placebo-Controlled Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Using MPC-5971 as Adjuvant Therapy in Subjects Undergoing Shock Wave Lithotripsy
The purpose of this study is to evaluate the efficacy of MP-5971 in facilitating stone passage after Shock Wave Lithotripsy treatment.
Read the detailed description
Shock Wave Lithotripsy (SWL) is widely utilized as a first line therapy in patients with renal calculi. SWL is associated with limited morbidity, however, complications relating to stone fragment passage after treatment can occur, the most serious being ureter obstruction. In addition, the growth and agglomeration of residual fragments after SWL treatment, in approximately 40% of patients, will lead to another stone episode within 12 months. Adjunct therapy with MPC-5971 should reduce the risk of complications of residual stone fragments by facilitating passage, preventing blockage and inhibiting growth and enlargement of residual fragments. This is based on MPC-5971's ability to increase urinary inhibitors against growth and agglomeration of stone fragments and by reducing urinary saturation of calcium oxalate and uric acid. The objective is to see a decrease in fragment complications and a significant increase in the stone free rate at 3 months following SWL treatment in combination with MPC-5971.
- Conditions
- Nephrolithiasis
- Being tested
- placebo, MPC-5971
- Keywords
- Kidney Calculi, Urolithiasis, Lithotripsy, potassium compounds, magnesium compounds
- Medical subject headings
- Nephrolithiasis, Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
After SWL treatment subjects will be randomized to receive either MPC-5971 or placebo. Two tablets of MPC-5971 or placebo will be taken orally twice a day (bid). This will give a daily dosage equal to 40 mEq of potassium, 20 mEq of magnesium and 60 mEq of citrate. MPC-5971 or placebo will be taken bid for 90 days beginning immediately after SWL treatment.
MPC-5971Drug
After SWL treatment subjects will be randomized to receive either MPC-5971 or placebo. Two tablets of MPC-5971 or placebo will be taken orally twice a day (bid). This will give a daily dosage equal to 40 mEq of potassium, 20 mEq of magnesium and 60 mEq of citrate. MPC-5971 or placebo will be taken bid for 90 days beginning immediately after SWL treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MPC-5971 Receives: Drug: MPC-5971 |
| 2 | Placebo comparator | placebo identical in appearance to study drug Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
stone free rate after SWL treatment
Measured: 12 weeks
Secondary outcomes (3)
increase in urine inhibitors
Measured: 4 week and 12 week
Reduced need for secondary procedures such as URS to clear obstructive fragments
Measured: 12 weeks
reduced stone/fragment area (mm2),percent change from the treatment stone area (mm2)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2009 (estimated)
- Study startApr 2010
- Primary completionNov 2010
- Study completionDec 2010
Why it stopped: Sponsor Corporate Business Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mission Pharmacal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860093
- Sponsor's protocol ID
- MPC-5971
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2009
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koenig K, Padalino P, Alexandrides G, Pak CY. Bioavailability of potassium and magnesium, and citraturic response from potassium-magnesium citrate. J Urol. 1991 Feb;145(2):330-4. doi: 10.1016/s0022-5347(17)38330-1.
PubMed 1988724Pak CY, Koenig K, Khan R, Haynes S, Padalino P; New Collective Author. Physicochemical action of potassium-magnesium citrate in nephrolithiasis. J Bone Miner Res. 1992 Mar;7(3):281-5. doi: 10.1002/jbmr.5650070306.
PubMed 1585829Ettinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2.
PubMed 9366314Gonzalez GB, Pak CY, Adams-Huet B, Taylor R, Bilhartz LE. Effect of potassium-magnesium citrate on upper gastrointestinal mucosa. Aliment Pharmacol Ther. 1998 Jan;12(1):105-10. doi: 10.1046/j.1365-2036.1998.00280.x.
PubMed 9692708Ruml LA, Wuermser LA, Poindexter J, Pak CY. The effect of varying molar ratios of potassium-magnesium citrate on thiazide-induced hypokalemia and magnesium loss. J Clin Pharmacol. 1998 Nov;38(11):1035-41. doi: 10.1177/009127009803801108.
PubMed 9824785Ruml LA, Gonzalez G, Taylor R, Wuermser LA, Pak CY. Effect of varying doses of potassium-magnesium citrate on thiazide-induced hypokalemia and magnesium loss. Am J Ther. 1999 Jan;6(1):45-50. doi: 10.1097/00045391-199901000-00007.
PubMed 10423646Ruml LA, Pak CY. Effect of potassium magnesium citrate on thiazide-induced hypokalemia and magnesium loss. Am J Kidney Dis. 1999 Jul;34(1):107-13. doi: 10.1016/s0272-6386(99)70115-0.
PubMed 10401023Wuermser LA, Reilly C, Poindexter JR, Sakhaee K, Pak CY. Potassium-magnesium citrate versus potassium chloride in thiazide-induced hypokalemia. Kidney Int. 2000 Feb;57(2):607-12. doi: 10.1046/j.1523-1755.2000.00881.x.
PubMed 10652038Jaipakdee S, Prasongwatana V, Premgamone A, Reungjui S, Tosukhowong P, Tungsanga K, Suwantrai S, Noppawinyoowong C, Maskasame S, Sriboonlue P. The effects of potassium and magnesium supplementations on urinary risk factors of renal stone patients. J Med Assoc Thai. 2004 Mar;87(3):255-63.
PubMed 15117041Tosukhowong P, Tungsanga K, Phongudom S, Sriboonlue P. Effects of potassium-magnesium citrate supplementation on cytosolic ATP citrate lyase and mitochondrial aconitase activity in leukocytes: a window on renal citrate metabolism. Int J Urol. 2005 Feb;12(2):140-4. doi: 10.1111/j.1442-2042.2005.01001.x.
PubMed 15733107Sriboonlue P, Jaipakdee S, Jirakulsomchok D, Mairiang E, Tosukhowong P, Prasongwatana V, Savok S. Changes in erythrocyte contents of potassium, sodium and magnesium and Na, K-pump activity after the administration of potassium and magnesium salts. J Med Assoc Thai. 2004 Dec;87(12):1506-12.
PubMed 15822549Odvina CV, Mason RP, Pak CY. Prevention of thiazide-induced hypokalemia without magnesium depletion by potassium-magnesium-citrate. Am J Ther. 2006 Mar-Apr;13(2):101-8. doi: 10.1097/01.mjt.0000149922.16098.c0.
PubMed 16645424Zerwekh JE, Odvina CV, Wuermser LA, Pak CY. Reduction of renal stone risk by potassium-magnesium citrate during 5 weeks of bed rest. J Urol. 2007 Jun;177(6):2179-84. doi: 10.1016/j.juro.2007.01.156.
PubMed 17509313
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Site Placebo-Controlled Randomized Double-Blind Study to Evaluate the Efficacy and Safety of Using MPC-5971 as Adjuvant Therapy in Subjects Undergoing Shock Wave Lithotripsy
- ClinicalTrials.gov ID
- NCT00860093
- Acronym / sponsor ID
- MPC-5971
- Conditions
- Nephrolithiasis
- Keywords
- Kidney Calculi, Urolithiasis, Lithotripsy, potassium compounds, magnesium compounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Corporate Business Decision
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Mission PharmacalIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Mar 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.
The purpose of this study is to evaluate the efficacy of MP-5971 in facilitating stone passage after Shock Wave Lithotripsy treatment.
Detailed description
Shock Wave Lithotripsy (SWL) is widely utilized as a first line therapy in patients with renal calculi. SWL is associated with limited morbidity, however, complications relating to stone fragment passage after treatment can occur, the most serious being ureter obstruction. In addition, the growth and agglomeration of residual fragments after SWL treatment, in approximately 40% of patients, will lead to another stone episode within 12 months. Adjunct therapy with MPC-5971 should reduce the risk of complications of residual stone fragments by facilitating passage, preventing blockage and inhibiting growth and enlargement of residual fragments. This is based on MPC-5971's ability to increase urinary inhibitors against growth and agglomeration of stone fragments and by reducing urinary saturation of calcium oxalate and uric acid. The objective is to see a decrease in fragment complications and a significant increase in the stone free rate at 3 months following SWL treatment in combination with MPC-5971.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MPC-5971MPC-5971 |
| 2 | Placebo comparator | Other: placeboplacebo identical in appearance to study drug |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subject aged > or equal to 18 to < or equal to 70.
- Subject has undergone a computerized tomography (CT) scan within 30 days of the screening visit.
- Subject has been diagnosed with single unilateral renal calculus (target treatment stone).
- Target treatment stone, is presumed to be of calcium composition and/or uric acid composition.
- Target treatment stone is between > or equal to 5 and < or equal to 15 mm in diameter.
Key exclusion criteria (26 listed)
- Current or past history of cystine stones or infection stones.
- Renal insufficiency, defined as serum creatinine value outside of the normal reference range.
- Currently has or had hyperkalemia within the past six months, defined as serum potassium outside of the normal reference range.
- Currently has or had hypermagnesemia within the past six months, defined as serum magnesium outside of the normal reference range.
- Active urinary tract infection.
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 |
|---|---|---|
| placeboAfter SWL treatment subjects will be randomized to receive either MPC-5971 or placebo. Two tablets of MPC-5971 or placebo will be taken orally twice a day (bid). This will give a daily dosage equal to 40 mEq of potassium, 20 mEq of magnesium and 60 mEq of citrate. MPC-5971 or placebo will be taken bid for 90 days beginning immediately after SWL treatment. | Other | 2 |
| MPC-5971After SWL treatment subjects will be randomized to receive either MPC-5971 or placebo. Two tablets of MPC-5971 or placebo will be taken orally twice a day (bid). This will give a daily dosage equal to 40 mEq of potassium, 20 mEq of magnesium and 60 mEq of citrate. MPC-5971 or placebo will be taken bid for 90 days beginning immediately after SWL treatment. | Drug | 1 |
Primary outcome
stone free rate after SWL treatment
Time frame: 12 weeks
3 secondary outcomes
increase in urine inhibitors
Time frame: 4 week and 12 week
Reduced need for secondary procedures such as URS to clear obstructive fragments
Time frame: 12 weeks
reduced stone/fragment area (mm2),percent change from the treatment stone area (mm2)
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Sponsor Corporate Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
- Background: PubMed 1988724Koenig K, Padalino P, Alexandrides G, Pak CY. Bioavailability of potassium and magnesium, and citraturic response from potassium-magnesium citrate. J Urol. 1991 Feb;145(2):330-4. doi: 10.1016/s0022-5347(17)38330-1.
- Background: PubMed 1585829Pak CY, Koenig K, Khan R, Haynes S, Padalino P; New Collective Author. Physicochemical action of potassium-magnesium citrate in nephrolithiasis. J Bone Miner Res. 1992 Mar;7(3):281-5. doi: 10.1002/jbmr.5650070306.
- Background: PubMed 9366314Ettinger B, Pak CY, Citron JT, Thomas C, Adams-Huet B, Vangessel A. Potassium-magnesium citrate is an effective prophylaxis against recurrent calcium oxalate nephrolithiasis. J Urol. 1997 Dec;158(6):2069-73. doi: 10.1016/s0022-5347(01)68155-2.
- Background: PubMed 9692708Gonzalez GB, Pak CY, Adams-Huet B, Taylor R, Bilhartz LE. Effect of potassium-magnesium citrate on upper gastrointestinal mucosa. Aliment Pharmacol Ther. 1998 Jan;12(1):105-10. doi: 10.1046/j.1365-2036.1998.00280.x.
- Background: PubMed 9824785Ruml LA, Wuermser LA, Poindexter J, Pak CY. The effect of varying molar ratios of potassium-magnesium citrate on thiazide-induced hypokalemia and magnesium loss. J Clin Pharmacol. 1998 Nov;38(11):1035-41. doi: 10.1177/009127009803801108.
- Background: PubMed 10423646Ruml LA, Gonzalez G, Taylor R, Wuermser LA, Pak CY. Effect of varying doses of potassium-magnesium citrate on thiazide-induced hypokalemia and magnesium loss. Am J Ther. 1999 Jan;6(1):45-50. doi: 10.1097/00045391-199901000-00007.
- Background: PubMed 10401023Ruml LA, Pak CY. Effect of potassium magnesium citrate on thiazide-induced hypokalemia and magnesium loss. Am J Kidney Dis. 1999 Jul;34(1):107-13. doi: 10.1016/s0272-6386(99)70115-0.
- Background: PubMed 10652038Wuermser LA, Reilly C, Poindexter JR, Sakhaee K, Pak CY. Potassium-magnesium citrate versus potassium chloride in thiazide-induced hypokalemia. Kidney Int. 2000 Feb;57(2):607-12. doi: 10.1046/j.1523-1755.2000.00881.x.
- Background: PubMed 15117041Jaipakdee S, Prasongwatana V, Premgamone A, Reungjui S, Tosukhowong P, Tungsanga K, Suwantrai S, Noppawinyoowong C, Maskasame S, Sriboonlue P. The effects of potassium and magnesium supplementations on urinary risk factors of renal stone patients. J Med Assoc Thai. 2004 Mar;87(3):255-63.
- Background: PubMed 15733107Tosukhowong P, Tungsanga K, Phongudom S, Sriboonlue P. Effects of potassium-magnesium citrate supplementation on cytosolic ATP citrate lyase and mitochondrial aconitase activity in leukocytes: a window on renal citrate metabolism. Int J Urol. 2005 Feb;12(2):140-4. doi: 10.1111/j.1442-2042.2005.01001.x.
- Background: PubMed 15822549Sriboonlue P, Jaipakdee S, Jirakulsomchok D, Mairiang E, Tosukhowong P, Prasongwatana V, Savok S. Changes in erythrocyte contents of potassium, sodium and magnesium and Na, K-pump activity after the administration of potassium and magnesium salts. J Med Assoc Thai. 2004 Dec;87(12):1506-12.
- Background: PubMed 16645424Odvina CV, Mason RP, Pak CY. Prevention of thiazide-induced hypokalemia without magnesium depletion by potassium-magnesium-citrate. Am J Ther. 2006 Mar-Apr;13(2):101-8. doi: 10.1097/01.mjt.0000149922.16098.c0.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 MPC-5971 in people with Nephrolithiasis, run by Mission Pharmacal at 3 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 12 inclusion and 26 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: stopped early, as of the sponsor's last update on 7 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was stopped early (reason given: Sponsor Corporate Business Decision). Results are not available in the source record.
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?
stone free rate after SWL treatment (time frame: 12 weeks). 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 NCT00860093, which also lists 13 linked publications.
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 7 Mar 2019.