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CompletedNCT00701805Updated Apr 19, 2011Results posted

Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

A Phase 2 interventional study of Paricalcitol in Secondary Hyperparathyroidism and Hemodialysis, sponsored by Abbott. Completed at 12 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-04-19.

Sponsored by Abbott · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
107
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).

Read the detailed description

The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).

02

Conditions studied

  • Secondary Hyperparathyroidism
  • Hemodialysis

Keywords

  • Secondary hyperparathyroidism
  • Hemodialysis
  • paricalcitol
03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 107 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients who completed 12 weeks of Study M10-309 (NCT00667576).

Exclusion criteria

Exclusion Criteria:

  • Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism.
  • Patients with progressive malignancy or clinically significant hepatic disease.
  • Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
  • Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    Paricalcitol 2 µg ± 1 µg

    Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.

    Drug: Paricalcitol

  • Experimental
    Paricalcitol 2 µg ± 2 µg

    Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.

    Drug: Paricalcitol

  • Experimental
    Paricalcitol 4 µg ± 1 µg

    Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.

    Drug: Paricalcitol

  • Experimental
    Paricalcitol 4 µg ± 2 µg

    Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment.

    Drug: Paricalcitol

Interventions

  • DrugParicalcitol

    Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

    Also known as: ABT-358, Zemplar

06

What researchers measure

Primary outcomes

  1. The Percentage of Participants With of Hypercalcemia

    The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during the 52 weeks of the study.

    Time frame: Anytime during the study through Week 53

  2. The Percentage of Participants With Hyperphosphatemia

    The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \>= 7.0 mg/dL during the 52 weeks of the study.

    Time frame: Anytime during the study through Week 53

Secondary outcomes

  1. The Mean Change in Intact Parathyroid Hormone (iPTH)

    Time frame: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)

  2. The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit

    Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

  3. The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%

    Time frame: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)

  4. Change in Mean iPTH

    Time frame: Every week from Baseline through Week 13 and every other week thereafter until Week 53

  5. Duration of 2 Consecutive Decreases in iPTH >= 50%

    Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

  6. Duration of 2 Consecutive iPTH Values <= 180 pg/mL

    Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)

  7. The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit

    Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

  8. The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit

    Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Other outcomes

  1. The Percentage of Participants With Hypercalcemia

    The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)

    Time frame: Anytime from Week 13 through Week 53

07

Results

Posted Apr 19, 2011
Limitations and caveats
The dose titration scheme was revised because of the incidence of hypercalcemia in the early weeks of the study.

Participant flow

A total of 107 of the 114 subjects who had completed Study M10-309 enrolled in this study, M10-312.

Participant flow — Overall Study
MilestoneParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
Started26292326
Completed23251622
Not completed3474
Withdrew: Withdrawal by subject3143
Withdrew: Adverse event0110
Withdrew: Missed 7 consecutive doses0100
Withdrew: Admitted to hospital for 2 weeks0010
Withdrew: Physician decision, change of therapy0001
Withdrew: Difficult to travel to dialysis site0010
Withdrew: Resumption criteria were not met0100

Outcome measures

PrimaryThe Percentage of Participants With of Hypercalcemia

The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during the 52 weeks of the study.

Time frame:
Anytime during the study through Week 53
Reported as:
Number · Percentage of participants
The Percentage of Participants With of Hypercalcemia
Percentage of participantsParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
The Percentage of Participants With of Hypercalcemia40.7463.3360.8765.38
PrimaryThe Percentage of Participants With Hyperphosphatemia

The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \>= 7.0 mg/dL during the 52 weeks of the study.

Time frame:
Anytime during the study through Week 53
Reported as:
Number · Percentage of participants
The Percentage of Participants With Hyperphosphatemia
Percentage of participantsParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
The Percentage of Participants With Hyperphosphatemia40.7436.6726.0938.46
SecondaryThe Mean Change in Intact Parathyroid Hormone (iPTH)
Time frame:
From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)
Reported as:
Mean · picograms/milliliter (pg/mL)
The Mean Change in Intact Parathyroid Hormone (iPTH)
picograms/milliliter (pg/mL)Paricalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
The Mean Change in Intact Parathyroid Hormone (iPTH)-263.7 (-342.59 to -184.80)-223.3 (-295.58 to -151.11)-248.3 (-308.16 to -188.36)-173.3 (-345.37 to -1.24)
SecondaryThe Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit
Time frame:
From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Reported as:
Number · Percentage of participants
The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit
Percentage of participantsParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
Subjects with iPTH <= 180 pg/mL42.341.439.138.5
Subjects with decrease in iPTH >= 50%57.751.756.557.7
SecondaryThe Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%
Time frame:
Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)
Reported as:
Number · Percentage of Participants
The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%
Percentage of ParticipantsParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%100.0100.0100.096.2
SecondaryChange in Mean iPTH
Time frame:
Every week from Baseline through Week 13 and every other week thereafter until Week 53
Reported as:
Mean · pg/mL
Change in Mean iPTH
pg/mLParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
Baseline517.7 ± 208.90502.5 ± 158.02510.9 ± 110.73519.7 ± 191.00
Week 1543.5 ± 227.63548.2 ± 186.89527.7 ± 126.04623.2 ± 250.76
Week 2472.5 ± 214.50478.8 ± 189.24408.0 ± 120.17490.3 ± 254.65
Week 3463.4 ± 219.02451.8 ± 198.15337.0 ± 130.90381.3 ± 233.11
Week 4363.7 ± 226.01378.9 ± 228.00286.8 ± 123.40291.7 ± 237.20
Week 5356.6 ± 250.28312.4 ± 204.53251.6 ± 97.55236.0 ± 192.90
Week 6292.4 ± 246.21244.7 ± 183.57222.6 ± 109.80228.8 ± 194.85
Week 7255.0 ± 213.14200.4 ± 157.93198.1 ± 110.03242.2 ± 172.47
Week 8241.5 ± 213.32185.3 ± 145.92200.0 ± 89.35242.5 ± 152.77
Week 9245.1 ± 226.00193.0 ± 139.02203.7 ± 99.57291.5 ± 225.08
Week 10232.3 ± 192.04219.7 ± 155.85231.6 ± 136.57247.5 ± 238.10
Week 11253.6 ± 160.57251.8 ± 170.12246.2 ± 146.08240.8 ± 216.55
Week 12237.7 ± 161.57267.1 ± 200.43277.3 ± 192.73266.2 ± 193.01
Week 13268.6 ± 205.67282.6 ± 192.29312.4 ± 205.30329.1 ± 236.15
Week 15264.2 ± 165.97317.3 ± 193.50359.4 ± 198.28357.4 ± 243.67
Week 17260.3 ± 150.59345.2 ± 242.46338.2 ± 172.23368.9 ± 290.14
Week 19235.3 ± 153.17314.9 ± 209.30332.9 ± 169.80357.0 ± 297.39
Week 21226.4 ± 133.54301.0 ± 188.52314.0 ± 100.02307.8 ± 233.98
Week 23238.5 ± 190.65309.3 ± 212.15315.4 ± 106.45323.7 ± 207.68
Week 25207.1 ± 159.00298.7 ± 207.91307.9 ± 137.16349.4 ± 246.98
Week 27233.8 ± 154.92293.6 ± 193.28271.7 ± 117.34349.3 ± 277.43
Week 29233.4 ± 169.07267.7 ± 173.87270.9 ± 161.03306.4 ± 217.70
Week 31241.3 ± 148.54287.9 ± 151.70257.1 ± 132.29285.7 ± 209.17
Week 33238.8 ± 151.08293.9 ± 175.41263.2 ± 122.00319.7 ± 285.10
Week 35242.4 ± 154.48290.7 ± 150.82227.3 ± 109.73336.0 ± 231.41
Week 37277.7 ± 155.17294.7 ± 176.56267.6 ± 144.44299.8 ± 241.77
Week 39275.5 ± 156.20316.0 ± 218.05236.9 ± 124.05296.7 ± 298.52
Week 41224.0 ± 119.93304.6 ± 163.90239.1 ± 108.72242.4 ± 115.27
Week 43249.8 ± 145.48319.4 ± 188.02277.9 ± 117.03246.2 ± 105.05
Week 45247.7 ± 148.75279.4 ± 171.65251.5 ± 88.42204.3 ± 96.70
Week 47250.2 ± 162.72272.0 ± 160.91204.2 ± 70.13240.2 ± 162.50
Week 49271.0 ± 183.26277.7 ± 212.64221.3 ± 102.75294.5 ± 213.57
Week 51278.0 ± 180.69295.0 ± 214.96267.5 ± 165.72283.0 ± 212.41
Week 53258.6 ± 173.45254.8 ± 143.86252.7 ± 163.02281.4 ± 221.18
SecondaryDuration of 2 Consecutive Decreases in iPTH >= 50%
Time frame:
From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Reported as:
Mean · days
Duration of 2 Consecutive Decreases in iPTH >= 50%
daysParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
Duration of 2 Consecutive Decreases in iPTH >= 50%60.6 ± 94.1338.8 ± 34.5147.2 ± 62.9830.2 ± 32.52
SecondaryDuration of 2 Consecutive iPTH Values <= 180 pg/mL
Time frame:
From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)
Reported as:
Mean · days
Duration of 2 Consecutive iPTH Values <= 180 pg/mL
daysParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
Duration of 2 Consecutive iPTH Values <= 180 pg/mL35.1 ± 50.5829.2 ± 20.1528.2 ± 24.3520.7 ± 33.43
Other pre-specifiedThe Percentage of Participants With Hypercalcemia

The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during Study M10-312 (Weeks 13 through 53)

Time frame:
Anytime from Week 13 through Week 53
Reported as:
Number · Percentage of participants
The Percentage of Participants With Hypercalcemia
Percentage of participantsParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
The Percentage of Participants With Hypercalcemia22.2243.3030.4346.15
SecondaryThe Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit
Time frame:
From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Reported as:
Number · Percentage of participants
The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit
Percentage of participantsParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit66.750.050.042.9
SecondaryThe Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit
Time frame:
From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)
Reported as:
Number · Percentage of participants
The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit
Percentage of participantsParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit50.080.050.072.7

Adverse events

Collected over All adverse events that occurred after the first dose of study drug up to 30 days after the last dose are reported. All serious adverse events are reported beginning with the time that the subject signed the study-specific informed consent form.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Paricalcitol 2 µg ± 1 µg—8/27 (29.6%)27/27 (100%)
Paricalcitol 2 µg ± 2 µg—6/30 (20%)30/30 (100%)
Paricalcitol 4 µg ± 1 µg—6/23 (26.1%)23/23 (100%)
Paricalcitol 4 µg ± 2 µg—4/26 (15.4%)26/26 (100%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
Shunt stenosisInjury, poisoning and procedural complications1/270/301/231/26
Myocardial infarctionCardiac disorders1/270/301/230/26
Angina pectorisCardiac disorders0/270/301/230/26
Cardiac failure acuteCardiac disorders0/270/301/230/26
Sudden deathGeneral disorders0/270/301/230/26
Tendon ruptureInjury, poisoning and procedural complications0/270/301/230/26
Cerebellar infarctionNervous system disorders0/270/301/230/26
Transient ischaemic attackNervous system disorders0/270/301/230/26
PneumoniaInfections and infestations1/270/300/231/26
Shunt occlusionInjury, poisoning and procedural complications1/270/300/231/26
Most frequent other events
Showing 10 of 87
Most frequent other events
EventParicalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µg
HypercalcaemiaMetabolism and nutrition disorders15/2723/3017/2322/26
NasopharyngitisInfections and infestations20/2720/3015/2315/26
HyperphosphataemiaMetabolism and nutrition disorders15/2722/3012/2316/26
HypertensionVascular disorders3/2711/300/235/26
ConstipationGastrointestinal disorders3/275/308/234/26
ContusionInjury, poisoning and procedural complications4/274/304/238/26
DiarrhoeaGastrointestinal disorders6/276/306/235/26
ArthralgiaMusculoskeletal and connective tissue disorders7/273/302/234/26
PruritusSkin and subcutaneous tissue disorders6/273/304/235/26
HyperkalaemiaMetabolism and nutrition disorders1/276/301/233/26

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Paricalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µgTotal
<=18 years00000
Between 18 and 65 years1617141663
>=65 years101291041
Age Continuous
Age Continuous(years)Paricalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µgTotal
Mean62.4 ± 11.8960.3 ± 12.0658.6 ± 12.1461.1 ± 11.9160.6 ± 11.90
Sex: Female, Male
Sex: Female, Male(Participants)Paricalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µgTotal
Female16136944
Male1016171760
Region of Enrollment
Region of Enrollment(participants)Paricalcitol 2 µg ± 1 µgParicalcitol 2 µg ± 2 µgParicalcitol 4 µg ± 1 µgParicalcitol 4 µg ± 2 µgTotal
Japan26292326104
08

Study locations

12 sites
  • Aichi, Japan
  • Chiba, Japan
  • Fukuoka, Japan
  • Hokkaido, Japan
  • Ibaragi, Japan
  • Kanagawa, Japan
  • Kumamoto, Japan
  • Nagano, Japan
  • Nagasaki, Japan
  • Osaka, Japan
  • Saitama, Japan
  • Tokyo, Japan
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00701805
Lead sponsor
Abbott
Collaborators
Abbott Japan Co.,Ltd
First posted
Jun 19, 2008
Start date
Jul 2008
Primary completion
Dec 2009
Completion
Dec 2009
Results posted
Apr 19, 2011
Last update
Apr 19, 2011

Study contacts

Moriaki KUBO
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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