ClinicalTrials.gg
Status unknownNCT03470961PAISPKUpdated Mar 20, 2018

Observational Study to Evaluate the Safety and Efficacy of Polyclonal Antibodies in Simultaneous Pancreas Kidney Transplant Recipients

A Phase 4 interventional study of Anti-Tlymphocyte Globulins and Anti-Thymocyte Globulins in CKD (Chronic Kidney Disease) Stage 5T, Diabetes Mellitus and Simultaneous Pancreas Kidney Transplantation, sponsored by Tianjin First Central Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-20.

Sponsored by Tianjin First Central Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Active, not recruiting — may be out of date.

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Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 245 studies in Renal Insufficiency, Chronic with a site in China — 94 open to participants now, 107 under way, 17 of them phase 3. Renal Insufficiency, Chronic · China.

Planned enrollment
131st of 164
45 · median 182
Started
2018
with 12 others
Phase 4
38 of 245
12 open now
Registered
67th of 245
by date

Among the 245 studies in Renal Insufficiency, Chronic with a site in China, this one is the 131st largest by planned enrollment of the 164 interventional ones that give a count, is one of 13 that started in 2018, is one of 38 in phase 4, and was the 67th registered.

Renal Insufficiency, Chronic

3,095 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.

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Open to participants now

94 of the 245 studies in Renal Insufficiency, Chronic with a site in China are open now. Recruiting first, the newest first:

89 more — sign in →

All 94 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 435 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study summary

A single-centre, prospective, observational study to evaluate the safety and efficacy of Polyclonal Antibodies in simultaneous Pancreas Kidney Transplant recipients.

Read the detailed description

Polyclonal antibody mainly contains Antit-Tlymphocyte globulins(Grafalon) and Anti-thymocyte globulins(ATG). To investigate the efficacy and safety of polyclonal antibodies induction regimen using Grafalon compared with ATG in de novo simultaneous pancreas kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate.

The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function), pancreas function and renal function

03

Conditions studied

  • CKD (Chronic Kidney Disease) Stage 5T
  • Diabetes Mellitus
  • Simultaneous Pancreas Kidney Transplantation

Keywords

  • Grafalon ATG SPK
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. with end-stage,diabetic nephropathy(type1or 2)
  2. Patients scheduled to undergo SPK with compatible ABO blood type.
  3. Peak PRA \<50%
  4. Females of must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of should be started 4 weeks prior to and during the whole study.
  5. Patient must have signed the Patient Form.
  6. Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.

Exclusion criteria

Exclusion Criteria:

  1. Patient is pregnant or breastfeeding.
  2. Patient has a positive T-cell crossmatch on the most recent serum specimen.
  3. Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the .
  4. Patient has or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
  5. Patient has been included in another clinical trial protocol for any drug within 4 weeks prior to randomisation.
  6. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
  7. Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
  8. Donor is older than 55 years of age
  9. patients with bacterial, viral or mycotic infections which are not under therapeutically control
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Anti-Tlymphocyte Globulins

    intravenous,2mg/kg/d,for 5 days

    Drug: Anti-Tlymphocyte Globulins

  • Active comparator
    Anti-thymocyte Globulins

    intravenous,1.5mg/kg/d,for 4 days

    Drug: Anti-Thymocyte Globulins

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse event

    Incidence of patient's death,graft loss,acute rejection

    Time frame: up to 3 months post-transplantation

07

Study locations

1 site
  • Tianjin First central hospital
    Tianjin, China
08

References and documents

Publications

  • Burkhalter F, Schaub S, Bucher C, Gurke L, Bachmann A, Hopfer H, Dickenmann M, Steiger J, Binet I. A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study. PLoS One. 2016 Nov 17;11(11):e0165233. doi: 10.1371/journal.pone.0165233. eCollection 2016. PubMed 27855166 ↗
  • Kuypers DR, Malaise J, Claes K, Evenepoel P, Maes B, Coosemans W, Pirenne J, Vanrenterghem Y; Euro-SPK Study Group. Secondary effects of immunosuppressive drugs after simultaneous pancreas-kidney transplantation. Nephrol Dial Transplant. 2005 May;20 Suppl 2:ii33-9, ii62. doi: 10.1093/ndt/gfh1080. PubMed 15814548 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Mar 2021, 36 months after the start.

Of 100 non-industry phase 4 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 67. This study's planned 36 months is below that.

Counting every sponsor, half of 116 studies reached it within 43 months; a quarter within 22 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2018
First posted
Mar 20, 2018
StartActual
Mar 1, 2018
Primary completionEst.
Mar 1, 2021
CompletionEst.
Mar 1, 2021
Last update
Mar 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03470961
Lead sponsor
Tianjin First Central Hospital
Responsible party
Yingxin FU.MD (Head of Department, Tianjin First Central Hospital) — Principal investigator
First posted
Mar 20, 2018
Start date
Mar 1, 2018
Primary completion
Mar 1, 2021 (estimated)
Completion
Mar 1, 2021 (estimated)
Last update
Mar 20, 2018

Study contacts

Yingxin FU, M.D
principal investigator · Tianjin First Central Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Anti-human t-lymphocyte immunoglobulin from rabbits · Thymoglobulin

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